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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K210072
Device Name HOLOSCOPE-i
Applicant
Real View Imaging Ltd.
4 Hatnufa St.
Yokneam,  IL 2069202
Applicant Contact Yehudit Kraizer
Correspondent
Real View Imaging Ltd.
4 Hatnufa St.
Yokneam,  IL 2069202
Correspondent Contact Yehudit Kraizer
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/11/2021
Decision Date 05/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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