The following data is part of a premarket notification filed by Deerfield Imaging, Inc. with the FDA for Imris Imri 3t V.
| Device ID | K212367 |
| 510k Number | K212367 |
| Device Name: | IMRIS IMRI 3T V |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Deerfield Imaging, Inc. 5101 Shady Oak Rd Minnetonka, MN 55343 |
| Contact | Tacy Brinkmeyer |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LNH |
| Subsequent Product Code | LNI |
| Subsequent Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-07-30 |
| Decision Date | 2021-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857534006745 | K212367 | 000 |
| 00857534006806 | K212367 | 000 |