PathPresenter Clinical Viewer 1.0

GUDID 00860012592500

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

Laboratory instrument/analyser application software IVD

• Primary Device ID: 00860012592500
• NIH Device Record Key: df42b8fc-1bc1-4ee0-a5e1-b4883fd648cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathPresenter Clinical Viewer
• Version Model Number: 1.0
• Catalog Number: 1.0
• Company DUNS: 117545480
• Company Name: PathPresenter, Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5195892543
• Email: brian@pathpresenter.com
• Phone: 5195892543
• Email: brian@pathpresenter.com
• Phone: 5195892543
• Email: brian@pathpresenter.com
• Phone: 5195892543
• Email: brian@pathpresenter.com
• Phone: 5195892543
• Email: brian@pathpresenter.com
• Phone: 5195892543
• Email: brian@pathpresenter.com
• Phone: 5195892543
• Email: brian@pathpresenter.com
• Phone: 5195892543
• Email: brian@pathpresenter.com
• Phone: 5195892543
• Email: brian@pathpresenter.com
• Phone: 5195892543
• Email: brian@pathpresenter.com
• Phone: 5195892543
• Email: brian@pathpresenter.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012592500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250968

FDA Product Code

• QKQ: Digital Pathology Image Viewing And Management Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-19
• Device Publish Date: 2025-08-11