DISCOGRAPHY KIT
Device Facts
| Record ID | K910503 |
|---|---|
| Device Name | DISCOGRAPHY KIT |
| Applicant | B. Braun of America, Inc. |
| Product Code | IZG · Radiology |
| Decision Date | Oct 7, 1991 |
| Decision | SESK |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1730 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
