Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615060

FEI Number

3009505338

Entity Name

APPLIED SPECTRAL IMAGING, LTD.

City/State/Country

Yokneam Northern, IL

Establishment Address

2 HaCarmel St., New Industrial Zone, Yokneam Northern 2069204, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

APPLIED SPECTRAL IMAGING Ltd. (Owner Number: 9031915)

Owner / Operator Contact Address

2 HaCarmel St., New Industrial Zone, Yokneam, IL-Z 2069204, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101291

PMA Number

N/A

All Registered Proprietary Names

CytoPower BandView HiBand BandView GenASIs BandView SpotScan UroVysion GenASIs Scan & Analysis UroVision PathFusion SpotScan UroVision HiFISH SpotScan UroVision CytoPower SpotScan UroVision SpotScan ALK CytoPower SpotScan ALK GenASIs Scan & Analysis ALK HiFISH SpotScan ALK ScanView ALK PathFusion SpotScan ALK SpotScan CEP XY CytoPower SpotScan CEP XY GenASIs Scan & Analysis CEP XY HiFISH SpotScan CEP XY HiFISH FISHView PathFusion FISHView CytoPower FISHView GenASIs FISHView HiFISH SpotScan HER2/neu PathFusion SpotScan HER2/neu CytoPower SpotScan HER2/neu GenASIs Scan & Analysis HER2/neu ScanView HER2/neu SpotScan HER2/neu

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNJ	Analyzer, Chromosome, Automated	Hematology	Class 2	864.5260	2007-10-24
NTH	System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays	Immunology	Class 2	866.4700	2011-11-02
NTH	System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays	Immunology	Class 2	866.4700	2013-02-20
JOY	Device, Automated Cell-Locating	Hematology	Class 2	864.5260	2007-10-24
LNJ	Analyzer, Chromosome, Automated	Hematology	Class 2	864.5260	2007-06-13
NTH	System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays	Immunology	Class 2	866.4700	2011-07-03

Official Correspondent

Yaniv Giron

US Agent Details

Reut Sagiv Business: APPLIED SPECTRAL IMAGING INC. Email: reut@spectral-imaging.com Phone: (800) 6113466

Related Public Records

Same Entity

APPLIED SPECTRAL IMAGING Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615060. Last updated year: 2026. Please use registration number 9615060 when referencing this establishment in official correspondence.