K142930

Substantially Equivalent

Exam Vue DR

Applicant: Jpi Healthcare Co, Ltd.
Product code: KPR
Advisory panel: Radiology
Date received: 2014-10-09
Decision date: 2015-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kuro 3-Dong, Kuro_Gu, KR

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.