K935435 is an FDA 510(k) clearance for the NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Victoreen, Inc. (Cleveland, US). The FDA issued a Cleared decision on July 29, 1994, 261 days after receiving the submission on November 10, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K935435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1993 |
| Decision Date | July 29, 1994 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IYE — Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |