The following data is part of a premarket notification filed by Mriguidance B.v with the FDA for Bonemri.
| Device ID | K202404 |
| 510k Number | K202404 |
| Device Name: | BoneMRI |
| Classification | Automated Radiological Image Processing Software |
| Applicant | MRIguidance B.V Gildstraat 91a Utrecht, NL 3572 El |
| Contact | Roel Raatgever |
| Correspondent | Suji Shetty Maxis Medical 7052 Hollow Lake Way San Jose, CA 95120 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-21 |
| Decision Date | 2021-12-22 |