Bonelogic
System, Image Processing, Radiological
Disior Ltd
The following data is part of a premarket notification filed by Disior Ltd with the FDA for Bonelogic.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06429810209023 | K203290 | 000 |
Trademark Results [Bonelogic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BONELOGIC 97301051 not registered Live/Pending |
Paragon 28, Inc. 2022-03-08 |
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