VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM— 510(k) K153548

Substantially Equivalent

Visionsense, Ltd.

FDA 510(k) clearance K153548 for VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM, Substantially Equivalent on 2016-02-22. Applicant: Visionsense, Ltd..

Clearance details

Applicant: Visionsense, Ltd.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2015-12-11
Decision date: 2016-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petach Tikva, Hamerkaz, IL

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.