The following data is part of a premarket notification filed by Aspect Imaging Ltd with the FDA for M2 Wrist Mri System.
| Device ID | K120701 |
| 510k Number | K120701 |
| Device Name: | M2 WRIST MRI SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ASPECT IMAGING LTD 20 HATA'AS ST (OPB 124) Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein ASPECT IMAGING LTD 20 HATA'AS ST (OPB 124) Kfar Saba, IL 44425 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-07 |
| Decision Date | 2013-02-07 |
| Summary: | summary |