Medical Device Manufacturer · US , Kirkland , WA

Confirma, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2002

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Confirma, Inc. Radiology ✕

9 devices

1-9 of 9

Cleared Nov 06, 2009

CADSTREAM VERSION 5

Radiology · 42d

Cleared Feb 02, 2009

CADSTREAM, VERSION 5.0

Radiology · 244d

Cleared Jul 09, 2007

CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS

Radiology · 34d

Cleared Mar 29, 2006

ACCESS BREAST COIL 4/SMS

Radiology · 28d

Cleared Aug 24, 2005

ACCESS BREAST COIL

Radiology · 27d

Cleared Jan 06, 2005

CADSTREAM VERSION 4.0

Radiology · 45d

Cleared Jul 07, 2004

CADSTREAM VERSION 3.1

Radiology · 78d

Cleared Aug 06, 2003

Radiology · 57d

Cleared Jan 15, 2002

Radiology · 78d