DX-480, ADD ON DIGITAL IMAGER— 510(k) K981880

Name: FDA 510(k) clearance K981880
Creator: U.S. Food and Drug Administration
Published: 1998-10-20

Substantially Equivalent

Wuestec Medical, Inc.

FDA 510(k) clearance K981880 for DX-480, ADD ON DIGITAL IMAGER, Substantially Equivalent on 1998-10-20. Applicant: Wuestec Medical, Inc.. Device class: 2.

Clearance details

Applicant: Wuestec Medical, Inc.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1998-05-28
Decision date: 1998-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mobile, AL, 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.