XPLORER 1590— 510(k) K062405

Substantially Equivalent

Imaging Dynamics Company , Ltd.

FDA 510(k) clearance K062405 for XPLORER 1590, Substantially Equivalent on 2006-09-13. Applicant: Imaging Dynamics Company , Ltd..

Clearance details

Applicant: Imaging Dynamics Company , Ltd.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2006-08-15
Decision date: 2006-09-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Calgary, Alberta, CA

Download summary PDF View on FDA.gov ↗

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.