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
1-19 of 19
Cleared Nov 09, 2017
Aquarius 8600 1417WCI
K173273 · MQB
Radiology · 28d
Cleared Oct 12, 2017
Aquarius 8600 1417TG and Aquarius 8600 1717TG
K171169 · MQB
Radiology · 174d
Cleared Oct 05, 2017
Aquarius 8600 1417WC
K171175 · MQB
Radiology · 167d
Cleared Feb 22, 2017
Aquarius 8600
K170202 · MQB
Radiology · 30d
Cleared May 27, 2011
INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
K111098 · MQB
Radiology · 37d
Cleared Jun 22, 2007
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
K071401 · KPR
Radiology · 32d
Cleared Jun 13, 2007
X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR
K071408 · KPR
Radiology · 23d
Cleared Jun 11, 2007
X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM
K071403 · KPR
Radiology · 21d
Cleared Jun 08, 2007
X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM
K071402 · KPR
Radiology · 18d
Cleared Jun 08, 2007
X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM
K071409 · KPR
Radiology · 18d
Cleared Jan 31, 2007
X3C DIGITAL RADIOGRAPHIC DETECTOR
K070079 · MQB
Radiology · 22d
Cleared Nov 22, 2006
XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND
K063246 · KPR
Radiology · 27d
Cleared Nov 22, 2006
XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND
K063247 · KPR
Radiology · 27d
Cleared Nov 02, 2006
XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM
K063039 · MQB
Radiology · 30d
Cleared Oct 06, 2006
ORTHOXP
K062634 · KPR
Radiology · 30d
Cleared Sep 29, 2006
XPLORER 1600 PLUS
K062586 · MQB
Radiology · 28d
Cleared Sep 15, 2006
XPLORER 1100
K062417 · KPR
Radiology · 28d
Cleared Sep 13, 2006
XPLORER 1590
K062405 · KPR
Radiology · 29d
Cleared Aug 17, 2006
XAMINER
K061595 · KPR
Radiology · 70d
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