K962627 is an FDA 510(k) clearance for the CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM. This device is classified as a System, Nuclear Magnetic Resonance Spectroscopic (Class II - Special Controls, product code LNI).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on April 3, 1997, 272 days after receiving the submission on July 5, 1996.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K962627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 1996 |
| Decision Date | April 03, 1997 |
| Days to Decision | 272 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 |