K013894 is an FDA 510(k) clearance for the TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Philips Medical Systems North America, Inc. (Bothell, US). The FDA issued a Cleared decision on January 18, 2002, 56 days after receiving the submission on November 23, 2001.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K013894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2001 |
| Decision Date | January 18, 2002 |
| 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 |