21 CFR 892.1730 — System, X-Ray, Photofluorographic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1730
Identification
A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IZG | System, X-Ray, Photofluorographic | 2 | 7 | 3rd Party |
| OIL | Discography Kit | 2 | 0 |
Special Controls
IZG — System, X-Ray, Photofluorographic
*Classification.* Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
eCFR
OIL — Discography Kit
*Classification.* Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
eCFR
