K902005 is an FDA 510(k) clearance for the MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Omega Medical Imaging, Inc. (Sanford, US). The FDA issued a Cleared decision on September 20, 1990, 139 days after receiving the submission on May 4, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K902005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1990 |
| Decision Date | September 20, 1990 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | JAA — System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |