K850571 is an FDA 510(k) clearance for the I-125 IMPLANT GUN. This device is classified as a System, Applicator, Radionuclide, Manual (Class I - General Controls, product code IWJ).
Submitted by Mick Radio-Nuclear Instruments, Inc. (Bronx, US). The FDA issued a Cleared decision on March 26, 1985, 41 days after receiving the submission on February 13, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5650.
| 510(k) Number | K850571 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1985 |
| Decision Date | March 26, 1985 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IWJ — System, Applicator, Radionuclide, Manual |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.5650 |