K162394 is an FDA 510(k) clearance for the CRC-77tHR. This device is classified as a Calibrator, Dose, Radionuclide (Class II - Special Controls, product code KPT).
Submitted by Capintec, Inc. (Florham Park, US). The FDA issued a Cleared decision on March 8, 2017, 194 days after receiving the submission on August 26, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1360.
| 510(k) Number | K162394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2016 |
| Decision Date | March 08, 2017 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPT - Calibrator, Dose, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1360 |