HealthJOINT

System, Image Processing, Radiological

Zebra Medical Vision Ltd.

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

Pre-market Notification Details

Device IDK202487
510k NumberK202487
Device Name:HealthJOINT
ClassificationSystem, Image Processing, Radiological
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 CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-31
Decision Date2020-12-04

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