AISight Dx

Primary DI
00860006696221
Brand
AISight Dx
Company
PathAI, Inc.
Model
11124001
Published
2025-07-08
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243391000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243391000AISight DxPathAI, Inc.2025-06-26QKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006696221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006696221008600066962218600066962210860006696221

GMDN Terms#

Term, Definition table
TermDefinition
Histology/cytology/microbiology image-analysis interpretive software IVDAn interpretive software program with image analysis algorithms [e.g., artificial intelligence (AI)-based] intended to be used in a digital pathology or microbiology laboratory to assist in the analysis of clinical specimens (e.g., biopsy, blood smear, urine) and/or microbial cultures for the quantitative/qualitative detection of cell markers (e.g., hormone receptors), changes in tissue architecture and/or cell morphological/physiological characteristics [e.g., nucleus size, cytoplasmic granularity, rate of cell division], and/or infectious microorganisms associated with a disease (e.g., breast cancer, malaria, UTI). Results are also interpreted by a clinician to guide patient management.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080255082
Device count
1
Lot or batch
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
03760408001005CaloPixTRIBUN HEALTHQKQ2025-07-15
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