HOLOSCOPE-i

System, Image Processing, Radiological

Real View Imaging Ltd.

The following data is part of a premarket notification filed by Real View Imaging Ltd. with the FDA for Holoscope-i.

Pre-market Notification Details

Device IDK210072
510k NumberK210072
Device Name:HOLOSCOPE-i
ClassificationSystem, Image Processing, Radiological
Applicant Real View Imaging Ltd. 4 Hatnufa St. Yokneam,  IL 2069202
ContactYehudit Kraizer
CorrespondentYehudit Kraizer
Real View Imaging Ltd. 4 Hatnufa St. Yokneam,  IL 2069202
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-11
Decision Date2021-05-14

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