Medical Device Manufacturer · CA , Calgary, Alberta

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

8 submissions · 8 cleared · Since 2006

Recent clearances: ResolutionMD, RESOLUTIONMD MOBILE, RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31

View 8 510(k) Devices ↓

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

Radiology · 125d

Cleared Mar 26, 2014

RESOLUTIONMD MOBILE

Radiology · 132d

Cleared Mar 14, 2013

RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31

Radiology · 154d

Cleared Apr 19, 2012

RESOLUTIONMD WEB

Radiology · 100d

Cleared Sep 09, 2011

RESOLUTIONMD MOBILE MODEL RMB-MOB-2X

Radiology · 119d

Cleared Feb 23, 2009

RESOLUTIONMD, RELEASE 2.1

Radiology · 161d

Cleared Jun 01, 2007

RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0

Radiology · 45d

Cleared Sep 22, 2006

RESOLUTIONMD, VERSION 1.3

Radiology · 56d