K905827 is an FDA 510(k) clearance for the FULL VIEW OMEGA TABLE. This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).
Submitted by Med-Tron Products, Inc. (Miller Place, US). The FDA issued a Cleared decision on January 28, 1991, 28 days after receiving the submission on December 31, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.
| 510(k) Number | K905827 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 1990 |
| Decision Date | January 28, 1991 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IYX — Camera, Scintillation (gamma) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1100 |