HealthMammo

Radiological Computer-assisted Prioritization Software For Lesions

Zebra Medical Vision Ltd.

The following data is part of a premarket notification filed by Zebra Medical Vision Ltd. with the FDA for Healthmammo.

Pre-market Notification Details

Device IDK200905
510k NumberK200905
Device Name:HealthMammo
ClassificationRadiological Computer-assisted Prioritization Software For Lesions
Applicant Zebra Medical Vision Ltd. Shefayim Commercial Center, PO Box 25 Shefayim,  IL 6099000
ContactFlair Bar
CorrespondentFlair Bar
Zebra Medical Vision Ltd. Shefayim Commercial Center, PO Box 25 Shefayim,  IL 6099000
Product CodeQFM  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-06
Decision Date2020-07-16

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