Medical Device Manufacturer · US , Wilmington , MA

Visualization Technology, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1996

Recent clearances: INSTATRAK 3000, SKULL BASE INSTATRAK SYSTEM, PEDIATRIC INSTATRAK SYSTEM

7

Total

7

Cleared

0

Denied

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

7 devices

1-7 of 7

Cleared Feb 12, 2001

INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500

Radiology · 90d

Cleared Mar 09, 2000

INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000

Radiology · 80d

Cleared Apr 15, 1999

STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH...

Radiology · 28d

Cleared Dec 31, 1998

Radiology · 84d

Cleared Nov 16, 1998

SKULL BASE INSTATRAK SYSTEM

Radiology · 81d

Cleared Aug 21, 1998

PEDIATRIC INSTATRAK SYSTEM

Radiology · 74d

Cleared Apr 08, 1996

Radiology · 75d