K101452 is an FDA 510(k) clearance for the CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW. This device is classified as a Calibrator, Dose, Radionuclide (Class II - Special Controls, product code KPT).
Submitted by Capintec, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on August 9, 2010, 76 days after receiving the submission on May 25, 2010.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1360.
| 510(k) Number | K101452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2010 |
| Decision Date | August 09, 2010 |
| Days to Decision | 76 days |
| Submission Type | Special |
| 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 |