FDA.reportPublic FDA data

GenASIs™ System

Primary DI
07290016630015
Brand
GenASIs™ System
Company
APPLIED SPECTRAL IMAGING LTD.
Model
GenASIs
Published
2018-01-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JOYDevice, Automated Cell-Locating
LNJAnalyzer, Chromosome, Automated
NOTMicroscope, Automated, Image Analysis, Operator Intervention
NQNMicroscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
NTHSystem, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOYDevice, Automated Cell-LocatingHematology2
LNJAnalyzer, Chromosome, AutomatedHematology2
NOTMicroscope, Automated, Image Analysis, Operator InterventionHematology2
NQNMicroscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent PositivityHematology2
NTHSystem, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) AssaysImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012103000
K050236000
K071398000
K101291000
K110345000
K122554000
K140957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012103000BANDVIEW SYSTEMApplied Spectral Imaging , Ltd.2001-09-14LNJ
K050236000FISHVIEWApplied Spectral Imaging , Ltd.2005-06-27LNJ
K071398000SCANVIEW, MODEL SC-300Applied Spectral Imaging , Ltd.2007-10-04JOY
K101291000SCANVIEW HER2/NEU FISH SYSTEMApplied Spectral Imaging , Ltd.2010-11-23NTH
K110345000SCANVIEW SYSTEMApplied Spectral Imaging2011-10-19NTH
K122554000GENASIS SCANVIEW SYSTEMApplied Spectral Imaging , Ltd.2013-02-07NTH
K140957000GENASIS HIPATH IHC FAMILYApplied Spectral Imaging , Ltd.2015-01-15NQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016630015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016630015072900166300157290016630015

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory analyser operation system software IVDMainframe or personal computer (PC) based operating system software (or firmware) that is specific to the central processing unit (CPU) incorporated into an analyser or analyser system. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a "version number" are commonly used to identify different operating system versions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600741763
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016630046ASI IVD SystemGenASIs 8.42024-07-02
07290016630039ASI IVD SystemGenASIs 8.32022-03-21
07290016630008GenASIs™ SystemGenASIs2017-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350040977194CellaVision® Remote Review Single EditionCellavision ABJOY2026-05-08
07290118610892X100HT SystemSCOPIO LABS LTDJOY2024-12-01
07290016630046ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.NQN2024-07-02
07290016630046ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.JOY2024-07-02
07290016630046ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.NOT2024-07-02
07290016630046ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.LNJ2024-07-02
07290016630046ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.NTH2024-07-02
07290018417034X100 Digital ScannerSCOPIO LABS LTDJOY2022-12-30
07290018417072X100 Processing Unit (Complete Unit)SCOPIO LABS LTDJOY2022-12-30
07290018417096X100HT Digital Scanner SCOPIO LABS LTDJOY2022-12-30
07290018417126X100HT Processing Unit SCOPIO LABS LTDJOY2022-12-30
07290018417133X100 with Full Field Peripheral Blood Smear ApplicationSCOPIO LABS LTDJOY2022-12-30
07290018417140X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationSCOPIO LABS LTDJOY2022-12-30
07290016630039ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.NOT2022-03-21
07290016630039ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.NQN2022-03-21
07290016630039ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.LNJ2022-03-21
07290016630039ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.NTH2022-03-21
07290016630039ASI IVD SystemAPPLIED SPECTRAL IMAGING LTD.JOY2022-03-21
07350040975091CellaVision DC-1Cellavision ABJOY2020-10-22
07350040975107CellaVision DC-1 PPACellavision ABJOY2020-10-22
00849832013488WIN10 CPU UPGRADE FOR GSL(IN WARRANTY)Leica Biosystems Richmond, Inc.JOY2019-11-09
00849832013495WIN10CPU UPGRADE FOR CAPTURE(INWARRANTY)Leica Biosystems Richmond, Inc.JOY2019-11-09
07350040974544CellaVision® Remote Review Software, Enterprise upgrade from Group Ed.Cellavision ABJOY2019-02-19
07350040974551CellaVision® Remote Review Software, Enterprise upgrade from Team Ed.Cellavision ABJOY2019-02-19
07350040974575CellaVision® Remote Review Software, Group upgrade from Team Ed.Cellavision ABJOY2019-02-19
07350040975893CellaVision® Remote Review Software, Professional Edition, version independentCellavision ABJOY2019-02-19
07350040975909CellaVision® Remote Review Software, Team Edition, version independentCellavision ABJOY2019-02-19
07350040975916CellaVision® Remote Review Software, Group Edition, version independentCellavision ABJOY2019-02-19
07350040975923CellaVision® Remote Review Software, Enterprise Edition, version independentCellavision ABJOY2019-02-19
07350040975930DI Remote Review Software version 6.x.xCellavision ABJOY2019-02-19