FDA.reportPublic FDA data

X100HT with Full Field Peripheral Blood Smear (PBS) Application

Primary DI
07290018417140
Brand
X100HT with Full Field Peripheral Blood Smear (PBS) Application
Company
SCOPIO LABS LTD
Model
SC-SYS-00002
Device description
X100HT with Processing Unit and FF-PBS application.Includes:- X100HT Scanner- X100HT Processing Unit- X100HT User Maintenance Kit
Published
2022-12-30
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
K201301000
K220013000
K243144000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201301000X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.2020-10-02JOY
K220013000X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.2022-05-03JOY
K243144000X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.2025-06-27JOY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018417140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018417140072900184171407290018417140

GMDN Terms#

Term, Definition table
TermDefinition
Cell morphology analyser IVD, automated/semi-automatedAn electrically-powered automated or semi-automated 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600369986
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018417034X100 Digital ScannerSC-SYS-000032022-12-30
07290018417072X100 Processing Unit (Complete Unit)SC-SYS-000042022-12-30
07290018417096X100HT Digital Scanner SC-SYS-000052022-12-30
07290018417126X100HT Processing Unit SC-SYS-000062022-12-30
07290018417133X100 with Full Field Peripheral Blood Smear ApplicationSC-SYS-000012022-12-30
07290118610892X100HT SystemSC-SYS-000172024-12-01

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
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
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