The following data is part of a premarket notification filed by Mrlguidance B.v. with the FDA for Bonemri V1.4.
| Device ID | K221762 |
| 510k Number | K221762 |
| Device Name: | BoneMRI V1.4 |
| Classification | Automated Radiological Image Processing Software |
| Applicant | MRlguidance B.V. Gildstraat 91a Utrecht, NL 3572 |
| Contact | Marijn Van Stralen |
| Correspondent | Sujith Shetty MAXIS Medical 3031 Tisch Way Suite 1010 San Jose, CA 95128 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-17 |
| Decision Date | 2022-11-16 |