The following data is part of a premarket notification filed by Aspect Imaging Ltd with the FDA for M2 Wrist 2 Mri System.
| Device ID | K130692 |
| 510k Number | K130692 |
| Device Name: | M2 WRIST 2 MRI SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ASPECT IMAGING LTD 291 HILLSIDE AVE. Somerset, MA 02726 |
| Contact | George Hattub |
| Correspondent | George Hattub ASPECT IMAGING LTD 291 HILLSIDE AVE. Somerset, MA 02726 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-13 |
| Decision Date | 2014-01-14 |
| Summary: | summary |