K912539 is an FDA 510(k) clearance for the SIGNA ADVANTAGE 0.5T MAGNETIC RESONANCE SYSTEM. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on September 27, 1991, 109 days after receiving the submission on June 10, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K912539 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 1991 |
| Decision Date | September 27, 1991 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LNH - System, Nuclear Magnetic Resonance Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |