FDA.reportPublic FDA data

Epredia

Primary DI
05051663010467
Brand
Epredia
Company
SHANDON DIAGNOSTICS LIMITED
Model
E1000 Dx Digital Pathology Solution
Catalog number
A85200002
Device description
The E1000 Dx Digital Pathology Solution is a high-capacity, automated whole slide imaging system for the creation, viewing, and management of digital images of surgical pathology slides. It allows whole slide digital images to be viewed on a display monitor that would otherwise be appropriate for manual visualization by conventional brightfield microscopy.The E1000 Dx Digital Pathology Solution consists of the following three components:Scanner component:E1000 Dx Digital Pathology Scanner with E1000 firmwareE1000 Dx Scanner SoftwareViewer component:E1000 Dx Image Management System (IMS) ServerE1000 Dx Viewer SoftwareDisplay component:Barco MDPC-8127
Published
2025-03-10
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
PSYWhole Slide Imaging System
PZZDigital Pathology Display
QKQDigital Pathology Image Viewing And Management Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSYWhole Slide Imaging SystemPathology2
PZZDigital Pathology DisplayPathology2
QKQDigital Pathology Image Viewing And Management SoftwarePathology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241717000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241717000E1000 Dx Digital Pathology SolutionShandon Diagnostics Limited2025-02-28PSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051663010467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051663010467050516630104675051663010467

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide digital imaging scanner IVDA mains electricity (AC-powered) device designed to be used in a histopathology laboratory to scan clinical specimens on microscope slides, at a microscopic level, to produce images in a digital format. Also known as a whole slide scanner or digital pathology slide scanning system, it is a bench-top unit with slide tray slots, high-resolution cameras, a user interface, and integrated software for image creation, viewing, and management to aid the pathologist to review and interpret slide images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
219103512
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051663626071EprediaLaser Embedding Cassettes - White110-01-10LMI2026-03-11
05051663626927EprediaLaser Embedding Cassettes - White110-01-10LMI2026-03-11
05051663011501EprediaAvantik QS12 Cryostat-UK956660-UK2025-11-07
05051663011518EprediaAvantik QS12 UV Cryostat-UK956661-UK2025-11-07
05051663011112EprediaHM525 NX Cryostat-UK956640-UK 2025-08-26
05051663011129EprediaHM525 NX UV Cryostat-UK956641-UK2025-08-26
05051663010580EprediaHM 355S Rotary Microtome-UK905200-UK2025-06-11
05051663518581EprediaRevos Chamber Filter Assembly KitA841101552024-06-13
05051663518598EprediaChamber Filter Tool KitA841101562024-06-13
05051663518604EprediaNose Cone Extraction Tool KitA841101572024-06-13
05051663010528EprediaHM 325 Rotary Microtome (UK made)902100-UK2024-05-10
05051663010559EprediaHM 340E Rotary Microtome (UK made)905190-UK 2024-05-10
05051663517362EprediaSLIP HOPPER 24x40mm #1.5A792100502024-02-16
05051663517379EprediaSLIP HOPPER 24x50mm #1.5A792100512024-02-16
05051663517386EprediaSLIP HOPPER 24x55mm #1.5A792100522024-02-16
05051663517393EprediaBasket Stand CompleteA792100562024-02-16
05051663517423EprediaSakura DRS2000 Basket (5)A792100662024-02-16
05051663517430EprediaSakura DRS2000 Basket (5)A792100672024-02-16
05051663517447EprediaSakura DRS2000 Basket (5)A792100682024-02-16
05051663517454EprediaVaristain V24-4 BasketA792100692024-02-16

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
07613336206737VENTANA DP 600 slide scannerRoche Diagnostics GmbHPSY2025-12-15
00884838124325Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2025-09-01
00884838124349Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2025-09-01
00860012592500PathPresenter Clinical ViewerPathPresenter, CorporationQKQ2025-08-11
03760408001005CaloPixTRIBUN HEALTHQKQ2025-07-15
00860006696221AISight DxPathAI, Inc.QKQ2025-07-08
00860006054595Concentriq AP-DxProscia Inc.PSY2025-05-08
07350092810593Sectra Digital Pathology ModuleSectra ABQKQ2025-04-09
05415334055919BarcoBarco NVPSY2025-04-08
05415334055926BarcoBarco NVPSY2025-04-08
05415334056244BarcoBarco NVPSY2025-04-08
05415334056251BarcoBarco NVPSY2025-04-08
06970027820902BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
06970027820940BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
06970027821077BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
06970027821084BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
00884838121263Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2025-02-24
00860006054557Concentriq AP-Dx-US Proscia Inc.PSY2025-01-15
00860006054557Concentriq AP-Dx-US Proscia Inc.QKQ2025-01-15
07350092810524Sectra Digital Pathology ModuleSectra ABQKQ2024-10-11
00884838121270Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2024-10-08
00860006054519Concentriq AP-DxProscia Inc.PSY2024-08-26
00860006054519Concentriq AP-DxProscia Inc.QKQ2024-08-26
00884838092105Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2024-07-15
00815477020525Aperio GT 450 DX (US) ScannerLEICA BIOSYSTEMS IMAGING, INCPSY2024-05-31
07350092810500Sectra Digital Pathology ModuleSectra ABQKQ2024-05-07