Data / Medical devices / Israel / Applied Spectral Imaging, Ltd.

Applied Spectral Imaging, Ltd.: FDA-registered device maker in Yokneam Northern, Israel, 7 510(k) clearances

Name: Applied Spectral Imaging, Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Applied Spectral Imaging, Ltd. is registered with the FDA (registration 9615060) in Yokneam Northern, Israel. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 15, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9615060
FEI number: 3009505338
Address: 2 HaCarmel St. New Industrial Zone, Yokneam Northern, Israel, 2069204
Owner or operator: APPLIED SPECTRAL IMAGING Ltd. (9031915)
Roles: Manufacturer
First device listed: June 13, 2007
Registered through: 2026
Brand names listed: CytoPower BandView, CytoPower FISHView, CytoPower MetScan, CytoPower SpotScan ALK, CytoPower SpotScan CEP XY, CytoPower SpotScan HER2/neu, CytoPower SpotScan UroVision, GenASIs BandView and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Chromosome, Automated	LNJ	2	Manufacturer	accessdata.fda.gov
Device, Automated Cell-Locating	JOY	2	Manufacturer	accessdata.fda.gov
Light, Microscope	IBJ	1	Manufacturer	accessdata.fda.gov
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity	NQN	2	Manufacturer	accessdata.fda.gov
Microscope, Automated, Image Analysis, Operator Intervention	NOT	2	Manufacturer	accessdata.fda.gov
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays	NTH	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 15, 2015	K140957	GENASIS HIPATH IHC FAMILY	NQN	Substantially Equivalent	Applied Spectral Imaging , Ltd.	accessdata.fda.gov
February 7, 2013	K122554	GENASIS SCANVIEW SYSTEM	NTH	Substantially Equivalent	Applied Spectral Imaging , Ltd.	accessdata.fda.gov
October 19, 2011	K110345	SCANVIEW SYSTEM	NTH	Substantially Equivalent	Applied Spectral Imaging	accessdata.fda.gov
November 23, 2010	K101291	SCANVIEW HER2/NEU FISH SYSTEM	NTH	Substantially Equivalent	Applied Spectral Imaging , Ltd.	accessdata.fda.gov
October 4, 2007	K071398	SCANVIEW, MODEL SC-300	JOY	Substantially Equivalent	Applied Spectral Imaging , Ltd.	accessdata.fda.gov
June 27, 2005	K050236	FISHVIEW	LNJ	Substantially Equivalent	Applied Spectral Imaging , Ltd.	accessdata.fda.gov
September 14, 2001	K012103	BANDVIEW SYSTEM	LNJ	Substantially Equivalent	Applied Spectral Imaging , Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 15, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.