The following data is part of a premarket notification filed by Disior Ltd with the FDA for Bonelogic.
| Device ID | K203290 |
| 510k Number | K203290 |
| Device Name: | Bonelogic |
| Classification | System, Image Processing, Radiological |
| Applicant | Disior Ltd Lapinlahdenkatu 16 Helsinki, FI 00180 |
| Contact | Markku Laitinen |
| Correspondent | Markku Laitinen Disior Ltd Lapinlahdenkatu 16 Helsinki, FI 00180 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-09 |
| Decision Date | 2021-02-05 |