K884912 is an FDA 510(k) clearance for the ANGIOSTAR. 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 February 16, 1989, 80 days after receiving the submission on November 28, 1988.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K884912 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 1988 |
| Decision Date | February 16, 1989 |
| Days to Decision | 80 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 |