K802578 is an FDA 510(k) clearance for the PACE-4-AUTOMATIC RIA GAMMA-COUTER. This device is classified as a Counter (beta, Gamma) For Clinical Use (Class I - General Controls, product code JJJ).
Submitted by Philips Medical Systems (Cleveland), Inc. (Walker, US). The FDA issued a Cleared decision on December 18, 1980, 59 days after receiving the submission on October 20, 1980.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 862.2320.
| 510(k) Number | K802578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1980 |
| Decision Date | December 18, 1980 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | JJJ — Counter (beta, Gamma) For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2320 |