FDA.reportPublic FDA data

PATHPRESENTER CORP

Matched from indexed company URL: Pathpresenter Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30394983873039498387PATHPRESENTER CORP1N2026-01-0119 Louis Dr Montville NJ US 07045

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860012592500PathPresenter Clinical Viewer - For In Vitro Diagnostic Use. The PathPresenter Clinical Viewer is a software intended for viewing and managing whole slide images of scanned glass sides derived from formalin fixed paraffin embedded (FFPE) tissue. It is an aid to pathologists to review and render a diagnosis using the digital images for the purposes of primary diagnosis. PathPresenter Clinical is not intended for use with frozen sections, cytology specimens, or non-FFPE specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using PathPresenter Clinical software. PathPresenter Clinical Viewer is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner NDPI image formats viewed on the Barco NV MDPC-8127 display device.5195892543brian@pathpresenter.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3422841896655415K250968PathPresenter Clinical ViewerQKQ2025-06-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QKQ12025-06-20

PMN#

GUDID#

PathPresenter Clinical Viewer - For In Vitro Diagnostic Use. The PathPresenter Clinical Viewer is a software intended for viewing and managing whole slide images of scanned glass sides derived from formalin fixed paraffin embedded (FFPE) tissue. It is an aid to pathologists to review and render a diagnosis using the digital images for the purposes of primary diagnosis. PathPresenter Clinical is not intended for use with frozen sections, cytology specimens, or non-FFPE specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using PathPresenter Clinical software. PathPresenter Clinical Viewer is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner NDPI image formats viewed on the Barco NV MDPC-8127 display device.

PathPresenter, Corporation

2025-08-11