Medical Device Manufacturer · CA , Calgary, Alberta

Calgary Scientific, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2006
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Calgary Scientific, Inc. Radiology ✕
8 devices
1-8 of 8
Cleared Aug 24, 2016
ResolutionMD
K161130 · LLZ
Radiology · 125d
Cleared Mar 26, 2014
RESOLUTIONMD MOBILE
K133508 · LLZ
Radiology · 132d
Cleared Mar 14, 2013
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31
K123186 · LLZ
Radiology · 154d
Cleared Apr 19, 2012
RESOLUTIONMD WEB
K120076 · LLZ
Radiology · 100d
Cleared Sep 09, 2011
RESOLUTIONMD MOBILE MODEL RMB-MOB-2X
K111346 · LLZ
Radiology · 119d
Cleared Feb 23, 2009
RESOLUTIONMD, RELEASE 2.1
K082693 · LLZ
Radiology · 161d
Cleared Jun 01, 2007
RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0
K071086 · LLZ
Radiology · 45d
Cleared Sep 22, 2006
RESOLUTIONMD, VERSION 1.3
K062164 · LLZ
Radiology · 56d
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