K961321 is an FDA 510(k) clearance for the GAMMA GUIDANCE SYSTEM. This device is classified as a Probe, Uptake, Nuclear (Class I - General Controls, product code IZD).
Submitted by Radiation Monitoring Devices, Inc. (Watertown, US). The FDA issued a Cleared decision on February 10, 1997, 311 days after receiving the submission on April 5, 1996.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1320.
| 510(k) Number | K961321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 1996 |
| Decision Date | February 10, 1997 |
| Days to Decision | 311 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZD — Probe, Uptake, Nuclear |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1320 |