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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Prioritization Software For Lesions
510(k) Number K190362
Device Name HealthPNX
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 Number892.2080
Classification Product Code
QFM  
Date Received02/15/2019
Decision Date 05/06/2019
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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