K031209 is an FDA 510(k) clearance for the GE 1.5T 8 CHANNEL TORSO COIL. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on May 23, 2003, 36 days after receiving the submission on April 17, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K031209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2003 |
| Decision Date | May 23, 2003 |
| Days to Decision | 36 days |
| Submission Type | Special |
| 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 |