OSCAR (OSCAR Prime, OSCAR Classic)— 510(k) K181943

Substantially Equivalent

Genoray Co., Ltd.

FDA 510(k) clearance K181943 for OSCAR (OSCAR Prime, OSCAR Classic), Substantially Equivalent on 2018-08-17. Applicant: Genoray Co., Ltd..

Clearance details

Applicant: Genoray Co., Ltd.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2018-07-20
Decision date: 2018-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.