FullFocusTM Whole Slide Image Viewer

Primary DI
00860007599101
Brand
FullFocusTM Whole Slide Image Viewer
Company
PAIGE.AI, INC.
Model
2.X
Device description
FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus renders the uploaded slide images and is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis.
Published
2021-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K201005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201005000FullFocusPaige.Ai, Inc.2020-07-15QKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007599101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007599101008600075991018600075991010860007599101

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

Regulatory Flags#

DUNS number
081368558
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007599118Paige Prostate1.X2021-11-10

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
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
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