Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

Classification. Class II.

Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Classification. Class II.

Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 892.9.

Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

Classification. Class II.

Identification. A radiographic anthropomorphic phantom is a device intended for medical purposes to simulate a human body for positioning radiographic equipment.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 892.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.

Classification. Class II.

Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.

Classification. Class II.

Identification. A radiographic ECG/respirator synchronizer is a device intended to be used tocoordinatean x-ray film exposure with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 892.9.

Identification. Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 892.9.

Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.

Classification. Class II.

Identification. A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 892.9.

Identification. A radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 892.9.

Identification. A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure.

Classification. Class II.

Identification. A radiographic film/cassette changer programmer is a device intended to be used to control the operations of a film or cassette changer during serial medical radiography.

Classification. Class II.

Identification. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 892.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Identification. A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 892.9.