K926083 is an FDA 510(k) clearance for the NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES. This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).
Submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on February 12, 1993, 73 days after receiving the submission on December 1, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.
| 510(k) Number | K926083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1992 |
| Decision Date | February 12, 1993 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYX — Camera, Scintillation (gamma) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1100 |