K011493 is an FDA 510(k) clearance for the MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY. This device is classified as a Calibrator, Dose, Radionuclide (Class II - Special Controls, product code KPT).
Submitted by Mentor Corp. (Eden Prairie, US). The FDA issued a Cleared decision on October 1, 2002, 504 days after receiving the submission on May 15, 2001.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1360.
| 510(k) Number | K011493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2001 |
| Decision Date | October 01, 2002 |
| Days to Decision | 504 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 |