Medical Device Manufacturer · CA , Calgary, Alberta

Imaging Dynamics Company , Ltd. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 2006

Recent clearances: Aquarius 8600 1417WCI, Aquarius 8600 1417TG and Aquarius 8600 1717TG, Aquarius 8600 1417WC

19
Total
19
Cleared
0
Denied

Imaging Dynamics Company, Ltd. is a Canadian manufacturer of radiology imaging devices. The company operates with a manufacturing facility in Calgary, Alberta. IDC specializes in digital radiography solutions, including CCD detectors, flat panel detectors, and multifunction X-ray systems for medical and veterinary applications.

The company has received 19 FDA 510(k) clearances from 19 total submissions between 2006 and 2017. All submissions focused on radiology devices. IDC's cleared portfolio includes the Aquarius 8600 series, X3C digital radiographic systems, and INNOVAXION platforms. The company is currently inactive, with no FDA clearances recorded in the past five years.

IDC was founded in 1995 and achieved significant milestones including Toronto Stock Exchange listing in 2005 and Deloitte Fast 500 recognition in 2008. The company's technology drew from aerospace applications, including charge-coupled device (CCD) detector configurations. Products were distributed across more than 40 countries globally.

Explore the complete list of cleared device names, product codes, and clearance dates in the FDA 510(k) database.

510(k) submissions have been managed by Kamm & Associates as regulatory consultant.

FDA 510(k) Regulatory Record - Imaging Dynamics Company , Ltd.

19 devices
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