K101492 is an FDA 510(k) clearance for the 8 CHANNEL CARDIAC PHASED ARRAY COIL. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Ge Healthcare Coils (Usa Instruments, Inc.) (Aurora, US). The FDA issued a Cleared decision on June 23, 2010, 22 days after receiving the submission on June 1, 2010.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K101492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2010 |
| Decision Date | June 23, 2010 |
| Days to Decision | 22 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 |