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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 K203290
Device Name Bonelogic
Disior Ltd
Lapinlahdenkatu 16
Helsinki,  FI 00180
Applicant Contact Markku Laitinen
Disior Ltd
Lapinlahdenkatu 16
Helsinki,  FI 00180
Correspondent Contact Markku Laitinen
Regulation Number892.2050
Classification Product Code
Date Received11/09/2020
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