K905653 is an FDA 510(k) clearance for the ADVANTX AFM ANGIO SYSTEM S1808. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on May 15, 1991, 148 days after receiving the submission on December 18, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K905653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 1990 |
| Decision Date | May 15, 1991 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | IZI - System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |