K073290 is an FDA 510(k) clearance for the ARTIS ZEE AND ZEEGO. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on February 11, 2008, 82 days after receiving the submission on November 21, 2007.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K073290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2007 |
| Decision Date | February 11, 2008 |
| Days to Decision | 82 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 |