K213735 is an FDA 510(k) clearance for the dS Sentinelle Breast 16ch 1.5T Coil. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Invivo Corporation (Business Trade Name: Philips) (Florida, US). The FDA issued a Cleared decision on August 8, 2022, 252 days after receiving the submission on November 29, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K213735 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2021 |
| Decision Date | August 08, 2022 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| 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 |