§1020.30. Diagnostic x-ray systems and their major components. — Inbound Citations

(b) Regulations published under §§ 1020.30, 1020.31, and 900.12(e) of this chapter that are relevant to equipment performance should also be consulted for a more complete understanding of the equipment performance requirements.

(1) Radiographic equipment designed for general purpose or special nonmammography procedures shall not be used for mammography. This prohibition includes systems that have been modified or equipped with special attachments for mammography. This requirement supersedes the implied acceptance of such systems in § 1020.31(f)(3) of this chapter.

(2) All radiographic equipment used for mammography shall be specifically designed for mammography and shall be certified pursuant to § 1010.2 of this chapter as meeting the applicable requirements of §§ 1020.30 and 1020.31 of this chapter in effect at the date of manufacture.

(i) All devices used in mammography must have met the applicable FDA premarket authorization requirements for medical devices of that type with that intended use.

(ii) A mammography unit that is converted from one mammographic modality to another is considered a new unit at the facility under this part and must, prior to clinical use, undergo a mammography equipment evaluation demonstrating compliance with applicable requirements. The facility must also follow its accreditation body's procedures for applying for accreditation of that unit.

(i) The assembly shall be capable of being fixed in any position where it is designed to operate. Once fixed in any such position, it shall not undergo unintended motion.

(ii) The mechanism ensuring compliance with paragraph (b)(3)(i) of this section shall not fail in the event of power interruption.

(i) Systems using screen-film image receptors shall provide, at a minimum, for operation with image receptors of 18 × 24 centimeters (cm) and 24 × 30 cm.

(ii) Systems using screen-film image receptors shall be equipped with moving grids matched to all image receptor sizes provided.

(iii) Systems used for magnification procedures shall be capable of operation with the grid removed from between the source and image receptor.

(5) For any mammography system with a light beam that passes through the x-ray beam-limiting device, the light shall provide an average illumination of not less than 160 lux (15 foot candles) at 100 cm or the maximum source-image receptor distance (SID), whichever is less.

(i) Systems used to perform noninterventional problem solving procedures shall have radiographic magnification capability available for use by the operator.

(ii) Systems used for magnification procedures shall provide, at a minimum, at least one magnification value within the range of 1.4 to 2.0.

(i) When more than one focal spot is provided, the system shall indicate, prior to exposure, which focal spot is selected.

(ii) When more than one target material is provided, the system shall indicate, prior to exposure, the preselected target material.

(iii) When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall display, after the exposure, the target material and/or focal spot actually used during the exposure.

(8) All mammography systems shall incorporate a compression device.

(i) Effective October 28, 2002, each system shall provide:

(A) An initial power-driven compression activated by hands-free controls operable from both sides of the patient; and

(A) Systems shall be equipped with different sized compression paddles that match the sizes of all full-field image receptors provided for the system. Compression paddles for special purposes, including those smaller than the full size of the image receptor (for “spot compression”) may be provided. Such compression paddles for special purposes are not subject to the requirements of paragraphs (b)(8)(ii)(D) and (b)(8)(ii)(E) of this section.

(B) Except as provided in paragraph (b)(8)(ii)(C) of this section, the compression paddle shall be flat and parallel to the breast support table and shall not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied.

(C) Equipment intended by the manufacturer's design to not be flat and parallel to the breast support table during compression shall meet the manufacturer's design specifications and maintenance requirements.

(D) The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor.

(E) The chest wall edge may be bent upward to allow for patient comfort but shall not appear on the image.

(i) Manual selection of milliampere seconds (mAs) or at least one of its component parts (milliapere (mA) and/or time) shall be available.

(ii) The technique factors (peak tube potential in kilovolt (kV) and either tube current in mA and exposure time in seconds or the product of tube current and exposure time in mAs) to be used during an exposure shall be indicated before the exposure begins, except when automatic exposure controls (AEC) are used, in which case the technique factors that are set prior to the exposure shall be indicated.

(iii) Following AEC mode use, the system shall indicate the actual kilovoltage peak (kVp) and mAs used during the exposure. The mAs may be displayed as mA and time.

(i) Each screen-film system shall provide an AEC mode that is operable in all combinations of equipment configuration provided, e.g., grid, nongrid; magnification, nonmagnification; and various target-filter combinations.

(ii) The positioning or selection of the detector shall permit flexibility in the placement of the detector under the target tissue.

(A) The size and available positions of the detector shall be clearly indicated at the X-ray input surface of the breast compression paddle.

(B) The selected position of the detector shall be clearly indicated.

(iii) The system shall provide means for the operator to vary the selected optical density from the normal (zero) setting.

(11) For facilities using screen-film units, the facility shall use x-ray film for mammography that has been designated by the film manufacturer as appropriate for mammography. For facilities using hardcopy prints of digital images for transfer, retention, or final interpretation purposes, the facility shall use a type of film designated by the film manufacturer as appropriate for these purposes and compatible with the printer being used.

(12) The facility shall use intensifying screens for mammography that have been designated by the screen manufacturer as appropriate for mammography and shall use film that is matched to the screen's spectral output as specified by the manufacturer.

(13) For processing mammography films, the facility shall use chemical solutions that are capable of developing the films used by the facility in a manner equivalent to the minimum requirements specified by the film manufacturer.

(14) The facility shall make special lights for film illumination, i.e., hot-lights, capable of producing light levels greater than that provided by the view box, available to the interpreting physicians.

(15) Facilities shall ensure that film masking devices that can limit the illuminated area to a region equal to or smaller than the exposed portion of the film are available to all interpreting physicians interpreting for the facility.

(16) Systems with image receptor modalities other than screen-film shall demonstrate compliance with quality standards by successful results of quality assurance testing as specified under paragraph (e)(6) of this section.

(c) Manufacturers of products subject to §§ 1020.30 through 1020.33 shall certify that each of their products meets all applicable requirements when installed into a diagnostic x-ray system according to instructions. This certification shall be made under the format specified in § 1010.2 of this chapter. Manufacturers may certify a combination of two or more components if they obtain prior authorization in writing from the Director, Center for Devices and Radiological Health. Manufacturers shall not be held responsible for noncompliance of their products if that noncompliance is due solely to the improper installation or assembly of that product by another person; however, manufacturers are responsible for providing assembly instructions adequate to assure compliance of their components with the applicable provisions of §§ 1020.30 through 1020.33.

(i) Section 1020.30(a);

(ii) Section 1020.30(b) “Technique factors”;

(3) CT conditions of operation means all selectable parameters governing the operation of a CT x-ray system including nominal tomographic section thickness, filtration, and the technique factors as defined in § 1020.30(b)(36).

(2) Manufacturers of electronic products listed in table 1 of this section if such product is sold exclusively to other manufacturers for use as components of electronic products to be sold to purchasers, with the exception that the provisions are applicable to those manufacturers certifying components of diagnostic x-ray systems pursuant to provisions of § 1020.30(c) of this chapter.

(4) Assemblers of diagnostic x-ray equipment subject to the provisions of § 1020.30(d) of this chapter, provided the assembler has submitted the report required by § 1020.30(d)(1) or (d)(2) of this chapter and retains a copy of such report for a period of 5 years from its date.

(4) Assemblers of diagnostic x-ray equipment subject to the provisions of § 1020.30(d) of this chapter, provided the assembler has submitted the report required by § 1020.30(d)(1) or (d)(2) of this chapter and retains a copy of such report for a period of 5 years from its date.

(4) Assemblers of diagnostic x-ray equipment subject to the provisions of § 1020.30(d) of this chapter, provided the assembler has submitted the report required by § 1020.30(d)(1) or (d)(2) of this chapter and retains a copy of such report for a period of 5 years from its date.

(1) The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID. The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam. The AKR due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic image receptor shall not exceed 3.34 × 10−3 percent of the entrance AKR, at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. Radiation therapy simulation systems shall be exempt from this requirement provided the systems are intended only for remote control operation and the manufacturer sets forth instructions for assemblers with respect to control location as part of the information required in § 1020.30(g). Additionally, the manufacturer shall provide to users, under § 1020.30(h)(1)(i), precautions concerning the importance of remote control operation.

(1) Means shall be provided to limit the source-skin distance to not less than 38 cm on stationary fluoroscopes and to not less than 30 cm on mobile and portable fluoroscopes. In addition, for fluoroscopes intended for specific surgical application that would be prohibited at the source-skin distances specified in this paragraph, provisions may be made for operation at shorter source-skin distances but in no case less than 20 cm. When provided, the manufacturer must set forth precautions with respect to the optional means of spacing, in addition to other information as required in § 1020.30(h).

(c) Each manufacturer of a CT x-ray system shall provide the following technical and safety information, in addition to that required under § 1020.30(h), to purchasers and, upon request, to others at a cost not to exceed the cost of publication and distribution of such information. This information shall be identified and provided in a separate section of the user's instruction manual or in a separate manual devoted only to this information.

(1) A statement of the CT conditions of operation used to provide the information required by paragraph (c) (2) and (3) of this section.

(2) The following dose information obtained by using the CT dosimetry phantom. For any CT x-ray system designed to image both the head and body, separate dose information shall be provided for each application. All dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuating materials present.

(i) (a) Along the axis of rotation of the phantom.

(b) Along a line parallel to the axis of rotation and 1.0 centimeter interior to the surface of the phantom with the phantom positioned so that CTDI is the maximum obtainable at this depth.

(c) Along lines parallel to the axis of rotation and 1.0 centimeter interior to the surface of the phantom at positions 90, 180, and 270 degrees from the position in paragraph (c)(2)(i)(b) of this section. The CT conditions of operation shall be the typical values suggested by the manufacturer for CT of the head or body. The location of the position where the CTDI is maximum as specified in paragraph (c)(2)(i)(b) of this section shall be given by the manufacturer with respect to the housing of the scanning mechanism or other readily identifiable feature of the CT x-ray system in such a manner as to permit placement of the dosimetry phantom in this orientation.

(ii) The CTDI in the center location of the dosimetry phantom for each selectable CT condition of operation that varies either the rate or duration of x-ray exposure. This CTDI shall be presented as a value that is normalized to the CTDI in the center location of the dosimetry phantom from paragraph (c)(2)(i) of this section, with the CTDI of paragraph (c)(2)(i) of this section having a value of one. As each individual CT condition of operation is changed, all other independent CT conditions of operation shall be maintained at the typical values described in paragraph (c)(2)(i) of this section. These data shall encompass the range of each CT condition of operation stated by the manufacturer as appropriate for CT of the head or body. When more than three selections of a CT condition of operation are available, the normalized CTDI shall be provided, at least, for the minimum, maximum, and mid-range value of the CT condition of operation.

(iii) The CTDI at the location coincident with the maximum CTDI at 1 centimeter interior to the surface of the dosimetry phantom for each selectable peak tube potential. When more than three selections of peak tube potential are available, the normalized CTDI shall be provided, at least, for the minimum, maximum, and a typical value of peak tube potential. The CTDI shall be presented as a value that is normalized to the maximum CTDI located at 1 centimeter interior to the surface of the dosimetry phantom from paragraph (c)(2)(i) of this section, with the CTDI of paragraph (c)(2)(i) of this section having a value of one.

(iv) The dose profile in the center location of the dosimetry phantom for each selectable nominal tomographic section thickness. When more than three selections of nominal tomographic section thicknesses are available, the information shall be provided, at least, for the minimum, maximum, and midrange value of nominal tomographic section thickness. The dose profile shall be presented on the same graph and to the same scale as the corresponding sensitivity profile required by paragraph (c)(3)(iv) of this section.

(v) A statement of the maximum deviation from the values given in the information provided according to paragraph (c)(2) (i), (ii), (iii), and (iv) of this section. Deviation of actual values may not exceed these limits.

(3) The following performance data shall be provided for the CT conditions of operation used to provide the information required by paragraph (c)(2)(i) of this section. All other aspects of data collection, including the x-ray attenuation properties of the material in the tomographic section, shall be similar to those used to provide the dose information required by paragraph (c)(2)(i) of this section. For any CT x-ray system designed to image both the head and body, separate imaging performance information shall be provided for each application.

(ii) A graphical presentation of the modulation transfer function for the same image processing and display mode as that used in the statement of the noise.

(iv) A graphical presentation of the sensitivity profile, at the location corresponding to the center location of the dosimetry phantom, for each selectable nominal tomographic section thickness for which the dose profile is given according to paragraph (c)(2)(iv) of this section.

(v) A description of the phantom or device and test protocol or procedure used to determine the specifications and a statement of the maximum deviation from the specifications provided in accordance with paragraphs (c)(3) (i), (ii), (iii), and (iv) of this section. Deviation of actual values may not exceed these limits.

(1) The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID. The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam. The AKR due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic image receptor shall not exceed 3.34 × 10−3 percent of the entrance AKR, at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. Radiation therapy simulation systems shall be exempt from this requirement provided the systems are intended only for remote control operation and the manufacturer sets forth instructions for assemblers with respect to control location as part of the information required in § 1020.30(g). Additionally, the manufacturer shall provide to users, under § 1020.30(h)(1)(i), precautions concerning the importance of remote control operation.

(4) Deviation of technique factors from indicated values shall not exceed the limits given in the information provided in accordance with § 1020.30(h)(3).

(f) During fluoroscopy and cinefluorography, x-ray tube potential and current shall be continuously indicated. Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with § 1020.30(h)(3).

(iv) Section 1020.30(h)(3)(vi) through (h)(3)(viii);

(iv) Section 1020.30(h)(3)(vi) through (h)(3)(viii);

(iv) Section 1020.30(h)(3)(vi) through (h)(3)(viii);

(4) The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope. The reference location shall be identified and described specifically in the information provided to users according to § 1020.30(h)(6)(iii).

(i) For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference locations shall be the respective locations specified in § 1020.32(d)(3)(i), (d)(3)(ii), or (d)(3)(v) for measuring compliance with air-kerma rate limits.

(ii) For C-arm fluoroscopes, the reference location shall be 15 cm from the isocenter toward the x-ray source along the beam axis. Alternatively, the reference location shall be at a point specified by the manufacturer to represent the location of the intersection of the x-ray beam with the patient's skin.

(iv) The HVL shall meet the specifications of § 1020.30(m)(1) of this chapter for the minimum HVL. These values, extrapolated to the mammographic range, are shown in table 2. Values not shown in table 2 may be determined by linear interpolation or extrapolation.

(2) Fluoroscopic systems manufactured on or after June 10, 2006, incorporating an x-ray tube(s) with a continuous output of 1 kilowatt or more and an anode heat storage capacity of 1 million heat units or more shall provide the option of adding x-ray filtration to the diagnostic source assembly in addition to the amount needed to meet the HVL provisions of § 1020.30(m)(1). The selection of this additional x-ray filtration shall be either at the option of the user or automatic as part of the selected mode of operation. A means of indicating which combination of additional filtration is in the x-ray beam shall be provided.

(v) Section 1020.30(n);

(iv) Equipment may be modified in accordance with § 1020.30(q) to comply with § 1020.32(d)(2). When the equipment is modified, it shall bear a label indicating the date of the modification and the statement: