K022337 is an FDA 510(k) clearance for the 3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on August 13, 2002, 26 days after receiving the submission on July 18, 2002.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K022337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2002 |
| Decision Date | August 13, 2002 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZL — System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |