PathPresenter Clinical Viewer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250968 FDA 510(k)
- FDA Product Code
- QKQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.3700 FDA 510(k)
- Regulation Number
- 864.3700 FDA 510(k)
- Advisory Committee
- Pathology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PathPresenter Clinical Viewer is a Digital Pathology Image Viewing and Management Software, designed for the examination and analysis of histopathological slides in pathology workflows. It facilitates the display, annotation, and sharing of digital pathology images, supporting diagnostic decision-making by pathologists and other healthcare professionals.
This software is intended for use in pathology laboratories and clinical settings, where it operates as a standalone or integrated system for viewing high-resolution digital slides. Supplied as a digital download, it requires compatible hardware and is not classified as a single-use or reusable device. The device adheres to FDA 510(k) clearance and IVDR compliance, with no specific sterility or MRI safety requirements noted. Registration numbers and product codes (e.g., QKQ, K250968) identify its regulatory classification under Device Class II for digital pathology applications.
Frequently asked questions
What is the PathPresenter Clinical Viewer used for in a pathology lab?
The PathPresenter Clinical Viewer is a software tool designed specifically for examining and analyzing digital histopathological slides in pathology workflows. It allows pathologists and healthcare professionals to display, annotate, and share high-resolution images, aiding in diagnostic decision-making. It functions as a standalone or integrated system for viewing these digital slides, streamlining the review process in clinical settings.
How is the PathPresenter Clinical Viewer supplied, and does it require any special hardware?
The PathPresenter Clinical Viewer is supplied as a digital download, meaning it is not a physical device. To use it, compatible hardware is required, as the software operates on a computer system rather than being a standalone machine. No specific hardware details are provided beyond this, so compatibility should be verified with your IT or pathology lab equipment.
Is the PathPresenter Clinical Viewer single-use or reusable, and does it have sterility requirements?
The PathPresenter Clinical Viewer is neither single-use nor reusable, as it is software that runs on a computer system. Since it is a digital product, there are no sterility requirements or concerns related to physical contamination. It adheres to regulatory standards for digital pathology software but does not involve physical materials that would require sterilization.
What regulatory pathways has the PathPresenter Clinical Viewer followed, and what class does it fall under?
The PathPresenter Clinical Viewer has undergone FDA 510(k) clearance and is compliant with the In Vitro Diagnostic Regulation (IVDR). It is classified under Device Class II for digital pathology applications, as indicated by its product code (QKQ) and regulatory submission details. This classification reflects its role in supporting diagnostic decision-making in pathology workflows.
Does the PathPresenter Clinical Viewer have any specific storage requirements or limitations?
Since the PathPresenter Clinical Viewer is a digital software solution, its primary storage requirement is a compatible computer system with sufficient memory and processing power to run the application. No physical storage conditions (like temperature or humidity) are specified, as the product does not involve physical materials. However, ensuring the system’s operating environment meets the software’s technical specifications is essential for optimal performance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K250968 | Class II | Active |
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Manufacturer
- Manufacturer
- Pathpresenter Corporation
Sources (2)
- FDA 510(k) K250968 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026