VISERA 4K UHD SYSTEM— 510(k) K151011

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K151011 for VISERA 4K UHD SYSTEM, Substantially Equivalent on 2015-10-01. Applicant: Olympus Medical Systems Corp..

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2015-04-15
Decision date: 2015-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.