CaloPix

Primary DI
03760408001005
Brand
CaloPix
Company
TRIBUN HEALTH
Model
6.1.0 IVDUS
Device description
CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue. CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.CaloPix is intended in viewing, interpreting and managing digital Whole Slide Images (WSI) of glass slides obtained from the Hamamatsu NanoZoomer S360MD slide scanner (NDPI file format) and viewed on the JVC Kenwood JD-C240BN01A display, as well as those obtained from the Leica Aperio GT 450 DX scanner (SVS file format) and viewed in the Dell U3223QE display.
Published
2025-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250414000CaloPixTribun Health2025-05-14QKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760408001005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760408001005037604080010053760408001005

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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33189200006support@tribun.health

Regulatory Flags#

DUNS number
263756971
Device count
1
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719896180012JelloXJelloX Biotech Inc.QKQ2026-05-18
07350092810685Sectra Digital Pathology ModuleSectra ABQKQ2026-05-12
G264APDX240HALO AP DxIndica Labs, Inc.QKQ2026-03-27
08809278790291INFINITT DPSINFINITT Healthcare Co.,Ltd.QKQ2026-01-29
00860012592500PathPresenter Clinical ViewerPathPresenter, CorporationQKQ2025-08-11
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