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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 K211803
Device Name HealthPPT
Applicant
Zebra Medical Vision Ltd.
Shefayim Commercial Center, PO Box 25
Sefayim,  IL 6099000
Applicant Contact Shlomit Cymbalista
Correspondent
Zebra Medical Vision Ltd.
Shefayim Commercial Center, PO Box 25
Sefayim,  IL 6099000
Correspondent Contact Shlomit Cymbalista
Regulation Number892.2080
Classification Product Code
QFM  
Date Received06/11/2021
Decision Date 12/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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