K192426 is an FDA 510(k) clearance for the Signa Voyager, Signa Voyager Quantum. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Ge Healthcare (Tianjin) Company Limited (Tianjin, CN). The FDA issued a Cleared decision on October 1, 2019, 26 days after receiving the submission on September 5, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K192426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2019 |
| Decision Date | October 01, 2019 |
| Days to Decision | 26 days |
| Submission Type | Special |
| 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 |