K910498 is an FDA 510(k) clearance for the MAGNETOM 42 SP AND 63 SP. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on March 25, 1991, 48 days after receiving the submission on February 5, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K910498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1991 |
| Decision Date | March 25, 1991 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | LNH — System, Nuclear Magnetic Resonance Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |