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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K223757
Device Name Bonelogic
Applicant
Disior Ltd
HTC Helsinki Building 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
LLZ  
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
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