DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16— 510(k) K080553

Name: FDA 510(k) clearance K080553
Creator: U.S. Food and Drug Administration
Published: 2008-04-16

Substantially Equivalent

Vieworks Co., Ltd.

FDA 510(k) clearance K080553 for DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16, Substantially Equivalent on 2008-04-16. Applicant: Vieworks Co., Ltd.. Device class: 2.

Clearance details

Applicant: Vieworks Co., Ltd.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2008-02-28
Decision date: 2008-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flintville, TN, US

Download summary PDF View on FDA.gov ↗

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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.