K091154 is an FDA 510(k) clearance for the UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,. This device is classified as a System, Applicator, Radionuclide, Remote-controlled (Class II - Special Controls, product code JAQ).
Submitted by Nucletron Corporation (Columbia, US). The FDA issued a Cleared decision on May 18, 2009, 27 days after receiving the submission on April 21, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5700.
| 510(k) Number | K091154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2009 |
| Decision Date | May 18, 2009 |
| Days to Decision | 27 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 |