K201615 is an FDA 510(k) clearance for the SIGNA 7.0T. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on October 15, 2020, 122 days after receiving the submission on June 15, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K201615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2020 |
| Decision Date | October 15, 2020 |
| Days to Decision | 122 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 |