FDA.reportPublic FDA data

Sectra Digital Pathology Module

Primary DI
07350092810685
Brand
Sectra Digital Pathology Module
Company
Sectra AB
Model
5.0
Device description
For In Vitro Diagnostic UseSectra Digital Pathology Module (3.3) is a software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.Sectra Digital Pathology Module (3.3) is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module (3.3) is intended for use with Leica’s Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.
Published
2026-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QKQDigital Pathology Image Viewing And Management Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKQDigital Pathology Image Viewing And Management SoftwarePathology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350092810685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350092810685073500928106857350092810685

GMDN Terms#

Term, Definition table
TermDefinition
Pathology information systemA dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of pathology services and facilities. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

Regulatory Flags#

DUNS number
354117848
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350092810654Sectra Workstation 28.12026-05-12
07350092810678Sectra Orthopedic Package19.22026-03-05
07350092810616Sectra Workstation 27.22025-10-27
07350092810609Sectra Orthopedic Package19.12025-07-17
07350092810593Sectra Digital Pathology Module4.22025-04-09
07350092810579Sectra Workstation 27.12025-04-08
07350092810562Sectra Orthopedic Package18.22025-01-12
07350092810524Sectra Digital Pathology Module4.12024-10-11
07350092810531Sectra Workstation 26.22024-10-11
07350092810555Sectra Orthopedic Package18.12024-08-21
07350092810517Sectra Workstation26.12024-06-04
07350092810500Sectra Digital Pathology Module4.02024-05-07
07350092810494Sectra Orthopedic Package17.22024-01-02
07350092810487Sectra Digital Pathology Module3.42023-11-13
07350092810470Sectra Workstation25.22023-11-12
07350092810449Sectra Workstation25.12023-06-21
07350092810456Sectra Digital Pathology Module3.32023-06-21
07350092810463Sectra Orthopedic Package17.12023-06-21
07350092810395Sectra Calibration Unit22022-11-07
07350092810432Sectra Orthopedic Package16.22022-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719896180012JelloXJelloX Biotech Inc.QKQ2026-05-18
G264APDX240HALO AP DxIndica Labs, Inc.QKQ2026-03-27
08809278790291INFINITT DPSINFINITT Healthcare Co.,Ltd.QKQ2026-01-29
00860012592500PathPresenter Clinical ViewerPathPresenter, CorporationQKQ2025-08-11
03760408001005CaloPixTRIBUN HEALTHQKQ2025-07-15
00860006696221AISight DxPathAI, Inc.QKQ2025-07-08
07350092810593Sectra Digital Pathology ModuleSectra ABQKQ2025-04-09
05051663010467EprediaSHANDON DIAGNOSTICS LIMITEDQKQ2025-03-10
00860006054557Concentriq AP-Dx-US Proscia Inc.QKQ2025-01-15
07350092810524Sectra Digital Pathology ModuleSectra ABQKQ2024-10-11
00860006054519Concentriq AP-DxProscia Inc.QKQ2024-08-26
07350092810500Sectra Digital Pathology ModuleSectra ABQKQ2024-05-07
07350092810487Sectra Digital Pathology ModuleSectra ABQKQ2023-11-13
07350092810456Sectra Digital Pathology ModuleSectra ABQKQ2023-06-21
00854904006039Synapse PathologyFujifilm Healthcare Americas CorporationQKQ2023-06-16
07350092810425Sectra Digital Pathology ModuleSectra ABQKQ2022-10-17
00860007120206Dynamyx Digital Pathology SoftwareOMNYX, LLCQKQ2022-04-21
07350092810388Sectra Digital Pathology ModuleSectra ABQKQ2022-03-30
00860007599101FullFocusTM Whole Slide Image ViewerPAIGE.AI, INC.QKQ2021-09-23
07350092810333Sectra Digital Pathology ModuleSectra ABQKQ2021-05-05
07350092810289Sectra Digital Pathology ModuleSectra ABQKQ2020-10-09
07350092810241Sectra Digital Pathology ModuleSectra ABQKQ2020-04-21
07350092810197Sectra Digital Pathology ModuleSectra ABQKQ2020-04-20