Medical Device Manufacturer · US , Hasbrouck Heights , NJ

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

10 submissions · 10 cleared · Since 2004
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
K102604 · JAK
Radiology · 27d
Cleared Sep 04, 2009
INREACH SYSTEM, MODEL AAS00161-02
K092365 · JAK
Radiology · 30d
Cleared Sep 16, 2008
INREACH PLANNING LAPTOP
K082386 · LLZ
Radiology · 28d
Cleared Jun 11, 2008
MODIFICATION TO INREACH SYSTEM
K081379 · JAK
Radiology · 26d
Cleared Mar 31, 2008
INREACH SYSTEM
K080271 · JAK
Radiology · 59d
Cleared Jul 12, 2007
MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2
K071473 · EOQ
Radiology · 44d
Cleared Sep 08, 2006
SUPERDIMENSION/BRONCHUS PREMIUM 2
K062315 · JAK
Radiology · 30d
Cleared Nov 14, 2005
SUPERDIMENSION/BRONCHUS PREMIUM
K052852 · JAK
Radiology · 34d
Cleared Sep 08, 2005
SUPERDIMENSION/BRONCHUS 4.1
K052260 · JAK
Radiology · 20d
Cleared Nov 08, 2004
SUPERDIMENSION/BRONCHUS
K042438 · JAK
Radiology · 61d
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