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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06429810209023 | K203290 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BONELOGIC 97301051 not registered Live/Pending |
Paragon 28, Inc. 2022-03-08 |