K173749 is an FDA 510(k) clearance for the AMRA Profiler. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Amra Medical AB (Linkoping, SE). The FDA issued a Cleared decision on December 6, 2018, 363 days after receiving the submission on December 8, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K173749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2017 |
| Decision Date | December 06, 2018 |
| Days to Decision | 363 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | LNH - System, Nuclear Magnetic Resonance Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |