FDA.reportPublic FDA data

VENTANA DP 600 slide scanner

Primary DI
07613336206737
Brand
VENTANA DP 600 slide scanner
Company
Roche Diagnostics GmbH
Model
09311360001
Catalog number
09311360001
Published
2025-12-15
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSYWhole Slide Imaging SystemPathology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336206737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336206737076133362067377613336206737

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
315028860
Device count
1
Serial number
true
Manufacturing date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860006054557Concentriq AP-Dx-US Proscia Inc.PSY2025-01-15
00884838121270Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2024-10-08
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05415334044289BARCOBarco NVPSY2023-12-19
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00854904006039Synapse PathologyFujifilm Healthcare Americas CorporationPSY2023-06-16
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