K230871

Substantially Equivalent

EXTRON 5; EXTRON 7

Applicant: DRTECH Corporation
Product code: OWB
Advisory panel: Radiology
Date received: 2023-03-30
Decision date: 2023-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

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.