Medical Device Manufacturer · US , Middleton , WI

Standard Imaging, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1992

Recent clearances: DOSEVIEW 3D, STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331, HDR 1000 PLUS WELL CHAMBER, MODEL 90008

View 10 510(k) Devices ↓

10

Total

10

Cleared

0

Denied

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

10 devices

1-10 of 10

Cleared Dec 27, 2010

Radiology · 59d

Cleared Nov 19, 2008

STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331

Radiology · 58d

Cleared Apr 11, 2006

HDR 1000 PLUS WELL CHAMBER, MODEL 90008

Radiology · 42d

Cleared Nov 15, 2004

STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM

Radiology · 45d

Cleared May 11, 2004

STANDARD IMAGING E.IMRT CALCULATOR

Radiology · 56d

Cleared Nov 09, 2001

STANDARD IMAGING IVB 1000 WELL CHAMBER

Radiology · 16d

Cleared Sep 28, 2000

MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER

Radiology · 16d

Cleared Aug 02, 2000

STANDARD IMAGING HDR 1000 PLUS ION CHAMBER

Radiology · 47d

Cleared Mar 16, 1994

STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM

Radiology · 37d

Cleared Aug 24, 1992

STANDARD IMAGING HDR 1000 ION CHAMBER

Radiology · 87d