HealthPPT

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 Healthppt.

Pre-market Notification Details

Device IDK211803
510k NumberK211803
Device Name:HealthPPT
ClassificationRadiological Computer-assisted Prioritization Software For Lesions
Applicant Zebra Medical Vision Ltd. Shefayim Commercial Center, PO Box 25 Sefayim,  IL 6099000
ContactShlomit Cymbalista
CorrespondentShlomit Cymbalista
Zebra Medical Vision Ltd. Shefayim Commercial Center, PO Box 25 Sefayim,  IL 6099000
Product CodeQFM  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-11
Decision Date2021-12-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290018016107 K211803 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.