Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K203290 |
Device Name |
Bonelogic |
Applicant |
Disior Ltd |
Lapinlahdenkatu 16 |
Helsinki,
FI
00180
|
|
Applicant Contact |
Markku Laitinen |
Correspondent |
Disior Ltd |
Lapinlahdenkatu 16 |
Helsinki,
FI
00180
|
|
Correspondent Contact |
Markku Laitinen |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/09/2020 |
Decision Date | 02/05/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|