The following data is part of a premarket notification filed by Blue Belt Technologies, Inc. with the FDA for Ri.hip Modeler.
| Device ID | K212040 |
| 510k Number | K212040 |
| Device Name: | RI.HIP MODELER |
| Classification | System, Image Processing, Radiological |
| Applicant | Blue Belt Technologies, Inc. 2905 Northwest Boulevard, Suite 40 Plymouth, MN 55441 |
| Contact | Michael Gosha |
| Correspondent | Michael Gosha Blue Belt Technologies, Inc. 2905 Northwest Boulevard, Suite 40 Plymouth, MN 55441 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-30 |
| Decision Date | 2022-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556805961 | K212040 | 000 |