Medical Device Manufacturer · US , Hasbrouck Heights , NJ

Superdimension, Ltd. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2004

Recent clearances: I-LOGIC INREACH SYSTEM, INREACH SYSTEM, MODEL AAS00161-02, INREACH PLANNING LAPTOP

View 10 510(k) Devices ↓

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Superdimension, Ltd. Radiology ✕

10 devices

1-10 of 10

Cleared Oct 07, 2010

I-LOGIC INREACH SYSTEM

Radiology · 27d

Cleared Sep 04, 2009

INREACH SYSTEM, MODEL AAS00161-02

Radiology · 30d

Cleared Sep 16, 2008

INREACH PLANNING LAPTOP

Radiology · 28d

Cleared Jun 11, 2008

MODIFICATION TO INREACH SYSTEM

Radiology · 26d

Cleared Mar 31, 2008

Radiology · 59d

Cleared Jul 12, 2007

MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2

Radiology · 44d

Cleared Sep 08, 2006

SUPERDIMENSION/BRONCHUS PREMIUM 2

Radiology · 30d

Cleared Nov 14, 2005

SUPERDIMENSION/BRONCHUS PREMIUM

Radiology · 34d

Cleared Sep 08, 2005

SUPERDIMENSION/BRONCHUS 4.1

Radiology · 20d

Cleared Nov 08, 2004

SUPERDIMENSION/BRONCHUS

Radiology · 61d