K903808 is an FDA 510(k) clearance for the AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT. This device is classified as a System, X-ray, Photofluorographic (Class II - Special Controls, product code IZG).
Submitted by Advanced Med/Surg, Inc. (Hayward, US). The FDA issued a Cleared decision on January 22, 1991, 155 days after receiving the submission on August 20, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1730.
| 510(k) Number | K903808 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1990 |
| Decision Date | January 22, 1991 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IZG — System, X-ray, Photofluorographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1730 |