Medical Device Manufacturer · US , Palo Alto , CA

Impac Medical Systems, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1991

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Impac Medical Systems, Inc. Radiology ✕

13 devices

1-13 of 13

Cleared Jul 07, 2015

Radiology · 60d

Cleared Sep 05, 2014

MOSAIQ ONCOLOGY INFORMATION SYSTEM

Radiology · 85d

Cleared Nov 20, 2013

Radiology · 58d

Cleared Dec 12, 2012

MOSAIQ ONCOLOGY INFORMATION SYSTEM

Radiology · 58d

Cleared Feb 28, 2012

MOSAIQ ONCOLOGY INFORMATION SYSTEM

Radiology · 50d

Cleared Dec 20, 2004

MODIFICATION TO: VIEWSTATION

Radiology · 10d

Cleared Nov 07, 2001

QWIKSIM VIRTUAL SIMULATION SYSTEM

Radiology · 15d

Cleared Aug 29, 2001

Radiology · 90d

Cleared Mar 27, 2000

Radiology · 360d

Cleared Jul 09, 1998

Radiology · 90d

Cleared Feb 06, 1997

Radiology · 234d

Cleared May 15, 1995

Radiology · 364d

Cleared Dec 19, 1991

Radiology · 127d