The following data is part of a premarket notification filed by Aspect Imaging Ltd with the FDA for Wrist 3.
| Device ID | K160185 |
| 510k Number | K160185 |
| Device Name: | Wrist 3 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ASPECT IMAGING LTD 27 SHAKED STREET Industrial Area Hevel Modi'in, IL 6085001 |
| Contact | Israel Citron |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858755006101 | K160185 | 000 |