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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K223757
Device Name Bonelogic
Applicant
Disior, Ltd.
Htc Helsinki Bldg. Pinta 4 Floor Tammasaarenkatu 3
Helsinki,  FI 00180
Applicant Contact Aarno Jussila
Correspondent
MCRA, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Alex Cadotte
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/15/2022
Decision Date 12/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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