HOLOSCOPE-i— 510(k) K210072

Substantially Equivalent

Real View Imaging , Ltd.

FDA 510(k) clearance K210072 for HOLOSCOPE-i, Substantially Equivalent on 2021-05-14. Applicant: Real View Imaging , Ltd..

Clearance details

Applicant: Real View Imaging , Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2021-01-11
Decision date: 2021-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.