OIL · Discography Kit
Radiology · 21 CFR 892.1730 · Class 2
Overview
| Product Code | OIL |
|---|---|
| Device Name | Discography Kit |
| Regulation | 21 CFR 892.1730 |
| Device Class | Class 2 |
| Review Panel | Radiology |
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.
Special Controls
*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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
