Applied Spectral Imaging L T D

FDA Filings

This page includes the latest FDA filings for Applied Spectral Imaging L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9615060
FEI Number3009505338
NameAPPLIED SPECTRAL IMAGING, LTD.
Owner & OperatorAPPLIED SPECTRAL IMAGING Ltd.
Contact Address2 HaCarmel St. New Industrial Zone
Yokneam IL-Z Ha Zafon 20692 IL
Official Correspondent
  • Shay Levav
  • 972-4-6547567-726
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2 HaCarmel St. New Industrial Zone
Yokneam Ha Zafon, 2069204 IL
Establishment TypeManufacture Medical Device



Registration Number3002691099
FEI Number3002691099
NameApplied Spectral Imaging Inc.
Owner & OperatorAPPLIED SPECTRAL IMAGING Ltd.
Contact Address2 HaCarmel St. New Industrial Zone
Yokneam IL-Z Ha Zafon 20692 IL
Official Correspondent
  • Shay Levav
  • 972-4-6547567-726
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address5315 Avenida Encinas, Suite 150
Carlsbad, CA 92008 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
APPLIED SPECTRAL IMAGING LTD.
ASI IVD System 2022-03-29
APPLIED SPECTRAL IMAGING LTD.
GenASIs™ System 2018-07-06
APPLIED SPECTRAL IMAGING LTD.
GenASIs™ System 2018-07-06
Applied Spectral Imaging Inc. [APPLIED SPECTRAL IMAGING Ltd.]
GenASIs2017-10-24
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
GenASIs2017-10-24
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
HiPath IHC Family2015-02-05
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
GenASIs HiPath IHC Family2015-02-05
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
HiPath IHC Family2015-02-05
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
GenASIs HiPath IHC Family2015-02-05
APPLIED SPECTRAL IMAGING LTD.
GENASIS HIPATH IHC FAMILY2015-01-15
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
SpotScan ALK2013-02-20
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
GenASIs Scan & Analysis ALK2013-02-20
APPLIED SPECTRAL IMAGING, LTD.
GENASIS SCANVIEW SYSTEM2013-02-07
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
SpotScan UroVysion2011-11-02
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
GenASIs Scan & Analysis UroVision2011-11-02
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
SpotScan HER2/neu2011-07-03
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
GenASIs Scan & Analysis HER2/neu2011-07-03
APPLIED SPECTRAL IMAGING, LTD.
SCANVIEW HER2/NEU FISH SYSTEM2010-11-23
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
SpotScan CEP XY2007-10-24
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
GenASIs Scan & Analysis CEP XY2007-10-24
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
GenASIs BandView2007-10-24
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
BandView2007-10-24
APPLIED SPECTRAL IMAGING, LTD.
SCANVIEW, MODEL SC-3002007-10-04
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
GenASIs FISHView2007-06-13
APPLIED SPECTRAL IMAGING, LTD. [APPLIED SPECTRAL IMAGING Ltd.]
FISHVIEW2007-06-13
APPLIED SPECTRAL IMAGING, LTD.
FISHVIEW2005-06-27
APPLIED SPECTRAL IMAGING, LTD.
BANDVIEW SYSTEM2001-09-14
APPLIED SPECTRAL IMAGING, LTD.
RETINAL CUBE1997-12-12

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