K913120 is an FDA 510(k) clearance for the POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on August 16, 1991, 32 days after receiving the submission on July 15, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K913120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1991 |
| Decision Date | August 16, 1991 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZI — System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |