K231647 is an FDA 510(k) clearance for the XENOVIEW 3.0T Chest Coil. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Polarean, Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on June 29, 2023, 24 days after receiving the submission on June 5, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K231647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2023 |
| Decision Date | June 29, 2023 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MOS - Coil, Magnetic Resonance, Specialty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |