FDA.reportPublic FDA data

Aperio GT 450 DX (US) Scanner

Primary DI
00815477020525
Brand
Aperio GT 450 DX (US) Scanner
Company
LEICA BIOSYSTEMS IMAGING, INC
Model
23GT450DXUS
Device description
Aperio GT 450 DX scanner is a WSI system comprised of an image acquisition subsystem known as the Aperio GT 450 DX scanner and Aperio WebViewer DX image viewing software which is accessed from a workstation and a display.
Published
2024-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00815477020525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815477020525008154770205258154770205250815477020525

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1 844 534 2262TechServices@leicabiosystems.com

Regulatory Flags#

DUNS number
063440460
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815477020259Aperio AT2 DX Scanner23AT2DX2020-01-23
00815477020051eIHC IVD bundle CS2- 250023CS2IVD-25002016-09-19
00815477020068eIHC IVD bundle AT Turbo-250023ATTIVD-25002016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04582389010734NanoZoomer S20MD Slide scanner systemHAMAMATSU PHOTONICS K.K.PSY2026-08-03
04582389011236NanoZoomer S540MD Slide scanner systemHAMAMATSU PHOTONICS K.K.PSY2026-08-03
04582389011267Agilent S540MD Slide Scanner SystemHAMAMATSU PHOTONICS K.K.PSY2026-08-03
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
00860006054595Concentriq AP-DxProscia Inc.PSY2025-05-08
05415334055919BarcoBarco NVPSY2025-04-08
05415334055926BarcoBarco NVPSY2025-04-08
05415334056244BarcoBarco NVPSY2025-04-08
05415334056251BarcoBarco NVPSY2025-04-08
05051663010467EprediaSHANDON DIAGNOSTICS LIMITEDPSY2025-03-10
00884838121263Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2025-02-24
00860006054557Concentriq AP-Dx-US Proscia Inc.PSY2025-01-15
00884838121270Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2024-10-08
00860006054519Concentriq AP-DxProscia Inc.PSY2024-08-26
00884838092105Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2024-07-15
05415334044289BARCOBarco NVPSY2023-12-19
05415334044371BARCOBarco NVPSY2023-12-19
00854904006039Synapse PathologyFujifilm Healthcare Americas CorporationPSY2023-06-16
04582389010659NanoZoomer S360MD Slide scanner systemHAMAMATSU PHOTONICS K.K.PSY2022-10-01
00815477020259Aperio AT2 DX ScannerLEICA BIOSYSTEMS IMAGING, INCPSY2020-01-23
00884838085640Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2017-12-15