FDA.reportPublic FDA data

CellaVision DC-1

Primary DI
07350040975091
Brand
CellaVision DC-1
Company
Cellavision AB
Model
XU-10301
Published
2020-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K200595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200595000CellaVision DC-1, CellaVision DC-1 PPACellaVision AB2020-10-16JOY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350040975091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350040975091073500409750917350040975091

GMDN Terms#

Term, Definition table
TermDefinition
Cell morphology analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used to capture digital images of a clinical specimen at the microscopic level in order to view, count, record and evaluate the morphological characteristics of the cells and other biological components. It is a computerized optical unit consisting of a microscope, camera and software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
508663101
Device count
1
Serial number
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
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
07350040974551CellaVision® Remote Review Software, Enterprise upgrade from Team Ed.CRRS-ENTE99CRRS-ENTE992019-02-19

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
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
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