iCAS-LV— 510(k) K231690

Substantially Equivalent

Highrad , Ltd.

FDA 510(k) clearance K231690 for iCAS-LV, Substantially Equivalent on 2024-03-01. Applicant: Highrad , Ltd..

Clearance details

Applicant: Highrad , Ltd.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2023-06-09
Decision date: 2024-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

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