K233600 is an FDA 510(k) clearance for the Smart Fit Knee 3.0T. 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 February 5, 2024, 88 days after receiving the submission on November 9, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K233600 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2023 |
| Decision Date | February 05, 2024 |
| Days to Decision | 88 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 |