K172611 is an FDA 510(k) clearance for the Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths. This device is classified as a System, Applicator, Radionuclide, Remote-controlled (Class II - Special Controls, product code JAQ).
Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on March 21, 2018, 202 days after receiving the submission on August 31, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5700.
| 510(k) Number | K172611 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2017 |
| Decision Date | March 21, 2018 |
| Days to Decision | 202 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAQ — System, Applicator, Radionuclide, Remote-controlled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5700 |