HealthOST

System, X-ray, Tomography, Computed

NanoxAI Ltd.

The following data is part of a premarket notification filed by Nanoxai Ltd. with the FDA for Healthost.

Pre-market Notification Details

Device IDK213944
510k NumberK213944
Device Name:HealthOST
ClassificationSystem, X-ray, Tomography, Computed
Applicant NanoxAI Ltd. Shefayim Commercial Center, PO Box 25 Shefayim,  IL 6099000
ContactShlomit Cymbalista
CorrespondentNeta Sherman
NanoxAI Ltd. Shefayim Commercial Center, PO Box 25 Shefayim,  IL 6099000
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-17
Decision Date2022-04-22

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