FDA.reportPublic FDA data

NanoZoomer S360MD Slide scanner system

Primary DI
04582389010659
Brand
NanoZoomer S360MD Slide scanner system
Company
HAMAMATSU PHOTONICS K.K.
Model
C13220-01MD
Published
2022-10-01
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213883000
K233027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213883000NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.2022-09-27PSY
K233027000NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.2023-12-22PSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582389010659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582389010659045823890106594582389010659

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
704524537
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582389010871PDE-GEN3C13999-402023-06-01
04582389010031PDEC9830-402016-09-23
04582389010062NIRO-200NXC10448-202016-09-23
04582389010093pde-neoC10935-402016-09-23
04582389010543pde-neoIIC10935-4002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00815477020525Aperio GT 450 DX (US) ScannerLEICA BIOSYSTEMS IMAGING, INCPSY2024-05-31
05415334044289BARCOBarco NVPSY2023-12-19
05415334044371BARCOBarco NVPSY2023-12-19
00854904006039Synapse PathologyFujifilm Healthcare Americas CorporationPSY2023-06-16
00815477020259Aperio AT2 DX ScannerLEICA BIOSYSTEMS IMAGING, INCPSY2020-01-23
00884838085640Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.PSY2017-12-15