DIGIARC 100AU+— 510(k) K141672

Substantially Equivalent

Beijing East Whale Imaging Technology Co., Ltd.

FDA 510(k) clearance K141672 for DIGIARC 100AU+, Substantially Equivalent on 2014-07-31. Applicant: Beijing East Whale Imaging Technology Co., Ltd..

Clearance details

Applicant: Beijing East Whale Imaging Technology Co., Ltd.
Product code: Code OXO
Advisory panel: Radiology
Date received: 2014-06-23
Decision date: 2014-07-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.