K003946 is an FDA 510(k) clearance for the SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on February 27, 2001, 68 days after receiving the submission on December 21, 2000.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K003946 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2000 |
| Decision Date | February 27, 2001 |
| Days to Decision | 68 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 |