K042844 is an FDA 510(k) clearance for the GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 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, Inc. (Milwaukee, US). The FDA issued a Cleared decision on November 3, 2004, 19 days after receiving the submission on October 15, 2004.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K042844 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2004 |
| Decision Date | November 03, 2004 |
| Days to Decision | 19 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 |