K161285 is an FDA 510(k) clearance for the Ablation Confirmation. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by Neuwave Medical, Inc. (Madision, US). The FDA issued a Cleared decision on June 29, 2016, 51 days after receiving the submission on May 9, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K161285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2016 |
| Decision Date | June 29, 2016 |
| Days to Decision | 51 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAK - System, X-ray, Tomography, Computed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |