K120701 is an FDA 510(k) clearance for the M2 WRIST MRI SYSTEM. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Aspect Imaging, Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on February 7, 2013, 337 days after receiving the submission on March 7, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K120701 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2012 |
| Decision Date | February 07, 2013 |
| Days to Decision | 337 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 |