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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 K202487
Device Name HealthJOINT
Applicant
Zebra Medical Vision Ltd.
Shefayim Commercial Center
PO Box 25
Shefayim,  IL 6099000
Applicant Contact Flair Bar
Correspondent
Zebra Medical Vision Ltd.
Shefayim Commercial Center
PO Box 25
Shefayim,  IL 6099000
Correspondent Contact Flair Bar
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/31/2020
Decision Date 12/04/2020
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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