FDA.reportPublic FDA data

CellaVision® Remote Review Software, Professional Edition, version independent

Primary DI
07350040975893
Brand
CellaVision® Remote Review Software, Professional Edition, version independent
Company
Cellavision AB
Model
CRRS-PR0099
Catalog number
CRRS-PR0099
Device description
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Published
2019-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOYDevice, Automated Cell-Locating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOYDevice, Automated Cell-LocatingHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092868000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092868000CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127CellaVision AB2009-11-20JOY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350040975893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350040975893073500409758937350040975893

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+46464601600service@cellavision.se

Regulatory Flags#

DUNS number
508663101
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350040977194CellaVision® Remote Review Single EditionCRRS-SI0099CRRS-SI00992026-05-08
07350040976753HemaPrepXU-10012-012023-01-06
07350040975091CellaVision DC-1XU-103012020-10-22
07350040975107CellaVision DC-1 PPAXU-103022020-10-22
07350040970201CellaVision® DM96XU-10020-01XU-10020-012016-09-20
07350040971277CellaVision® DM1200XU-10127-01XU-10127-012016-09-20
07350040972021Automated Digital Morphology Analyzer DI-60CC286297CC2862972016-09-20
07350040974322CellaVision® DM9600XU-10288-01XU-10288-012016-09-20
07350040972557CellaVision® Body Fluid Application DM1200CBF-120099CBF-1200992016-09-20
07350040972564CellaVision® Body Fluid Application DM96CBF-960099CBF-9600992016-09-20
07350040973707CellaVision® Remote Review Software version 5.0.x, Annual licenseCRRS-005001CRRS-0050012016-09-23
07350040973714CellaVision® Remote Review Software version 5.0.x, Non-expiring licenseCRRS-005099CRRS-0050992016-09-23
07350040973745CellaVision® Advanced RBC Application DM1200CAR-120099CAR-1200992018-03-05
07350040973752CellaVision® Advanced RBC Application DM96CAR-960099CAR-9600992018-03-05
07350040973769CellaVision® Advanced RBC Application DM9600CAR-970099CAR-9700992018-03-05
07350040973776CellaVision® Body Fluid Application DM9600CBF-970099CBF-9700992016-09-20
07350040974506CellaVision® Remote Review Software version 6.0.x, Annual licenseCRRS-006001CRRS-0060012016-09-23
07350040974513CellaVision® Remote Review Software version. 6.0.x, Non-expiring licenseCRRS-006099CRRS-0060992016-09-23
07350040974537CellaVision® Remote Review Software, Enterprise Edition, version 6.0.xCRRS-EN6099CRRS-EN60992016-09-23
07350040974544CellaVision® Remote Review Software, Enterprise upgrade from Group Ed.CRRS-ENGR99CRRS-GRGR992019-02-19

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.JOY2024-07-02
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.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
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
04987562444779Fully Automated Urine Particle Digital Imaging Device UD-10SYSMEX CORPORATIONJOY2018-12-11
07350040973745CellaVision® Advanced RBC Application DM1200Cellavision ABJOY2018-03-05
07350040973752CellaVision® Advanced RBC Application DM96Cellavision ABJOY2018-03-05
07350040973769CellaVision® Advanced RBC Application DM9600Cellavision ABJOY2018-03-05
07350040974759For DI Advanced RBC Application Cellavision ABJOY2018-03-05
07290016630015GenASIs™ SystemAPPLIED SPECTRAL IMAGING LTD.JOY2018-01-25
07290016630008GenASIs™ SystemAPPLIED SPECTRAL IMAGING LTD.JOY2017-01-12
00849832003304Leica Biosystems CytoVision GSL10 scanning sys for Karyotyping&FISHLeica Biosystems Richmond, Inc.JOY2016-11-21
00849832003342Leica Biosystems CytoVision MB8 scanning system for Karyotyping&FISHLeica Biosystems Richmond, Inc.JOY2016-11-14