K062623 is an FDA 510(k) clearance for the AXIOM LUMINOS DRF. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on August 22, 2007, 351 days after receiving the submission on September 5, 2006.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K062623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2006 |
| Decision Date | August 22, 2007 |
| Days to Decision | 351 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB — Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |