K062454 is an FDA 510(k) clearance for the MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Siemens Medi Cal Solutions, Inc. (Mavern, US). The FDA issued a Cleared decision on November 3, 2006, 73 days after receiving the submission on August 22, 2006.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K062454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2006 |
| Decision Date | November 03, 2006 |
| Days to Decision | 73 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 |