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136
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Applied Spectral Imaging , Ltd.
Medical Device Manufacturer
·
IL , Ra'Ananna 43373
Applied Spectral Imaging , Ltd. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1997
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Applied Spectral Imaging , Ltd.
Pathology
✕
5
devices
1-5 of 5
Filters
Cleared
Jan 15, 2015
GENASIS HIPATH IHC FAMILY
K140957
·
NQN
Pathology
·
276d
Cleared
Feb 07, 2013
GENASIS SCANVIEW SYSTEM
K122554
·
NTH
Pathology
·
170d
Cleared
Nov 23, 2010
SCANVIEW HER2/NEU FISH SYSTEM
K101291
·
NTH
Pathology
·
200d
Cleared
Jun 27, 2005
FISHVIEW
K050236
·
LNJ
Pathology
·
147d
Cleared
Sep 14, 2001
BANDVIEW SYSTEM
K012103
·
LNJ
Pathology
·
71d
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7
Pathology
5
Ophthalmic
1
Hematology
1