K003575 is an FDA 510(k) clearance for the MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM. This device is classified as a System, Nuclear Magnetic Resonance Spectroscopic (Class II - Special Controls, product code LNI).
Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on January 17, 2001, 58 days after receiving the submission on November 20, 2000.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K003575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2000 |
| Decision Date | January 17, 2001 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LNI - System, Nuclear Magnetic Resonance Spectroscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |