K123681 is an FDA 510(k) clearance for the 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Wipro GE Healthcare Private, Ltd. (Bangalore, IN). The FDA issued a Cleared decision on February 22, 2013, 84 days after receiving the submission on November 30, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K123681 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2012 |
| Decision Date | February 22, 2013 |
| Days to Decision | 84 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 |