K232021 is an FDA 510(k) clearance for the Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Philips Healthcare (Suzhou) Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on September 1, 2023, 56 days after receiving the submission on July 7, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K232021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2023 |
| Decision Date | September 01, 2023 |
| Days to Decision | 56 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 |