XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND— 510(k) K063247

Name: FDA 510(k) clearance K063247
Creator: U.S. Food and Drug Administration
Published: 2006-11-22

Substantially Equivalent

Imaging Dynamics Company , Ltd.

FDA 510(k) clearance K063247 for XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND, Substantially Equivalent on 2006-11-22. Applicant: Imaging Dynamics Company , Ltd.. Device class: 2.

Clearance details

Applicant: Imaging Dynamics Company , Ltd.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2006-10-26
Decision date: 2006-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Calgary, Alberta, CA

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.