K110610 is an FDA 510(k) clearance for the 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on April 1, 2011, 29 days after receiving the submission on March 3, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K110610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2011 |
| Decision Date | April 01, 2011 |
| Days to Decision | 29 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 |