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FullFocus

by Paige.AI, Inc. EUDAMED510(k)

Active European Union and United States

510(k) K241273

Overview

FullFocus is a Digital Pathology Image Viewing and Management Software designed for pathology workflows. It enables pathologists to analyze, annotate, and manage high-resolution digital pathology images, supporting diagnostic decision-making and collaboration in a structured, cloud-based environment.

The software is supplied as a cloud-based platform, intended for use in pathology laboratories and diagnostic settings. It operates as a single-use application per user session, with no physical sterility requirements. Compliance is governed under FDA 510(k) clearance and IVDR, adhering to regulatory standards for digital pathology tools in the United States and European Union.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK241273 Date9 Jan 2025ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
QKQ
Device Class
Class II
Regulation
21 CFR Part 864.3700
Advisory Committee
Pathology
FDA Decision
SESE Substantially Equivalent

Other devices from Paige.AI, Inc.

  • FullFocus

    Class II

Questions

  • What type of environment is FullFocus designed for, and how is it accessed by users?

    FullFocus is a cloud-based software platform specifically designed for pathology laboratories and diagnostic settings. It enables pathologists to remotely access, analyze, annotate, and manage high-resolution digital pathology images. Since it operates in the cloud, users do not need physical hardware beyond a compatible device with internet access, eliminating the need for on-site installation or maintenance.

  • Is FullFocus intended for single-use or repeated use by the same user, and does it require sterilization?

    FullFocus operates as a single-use application per user session, meaning each individual session is isolated and does not carry over data or settings between users. Because it is a software solution, there are no physical components that require sterilization, as sterility is not applicable to digital tools.

  • What regulatory pathways does FullFocus follow, and where is it currently authorized for use?

    FullFocus has obtained regulatory clearance through the FDA’s 510(k) process, specifically under the Traditional pathway, and is also compliant with the EU’s In Vitro Diagnostic Regulation (IVDR). This means it is authorized for use in the United States and the European Union, adhering to their respective standards for digital pathology software.

  • How does FullFocus support collaboration among pathologists, and what features does it provide for diagnostic workflows?

    FullFocus is structured as a cloud-based platform that facilitates collaboration by allowing multiple pathologists to access, annotate, and review the same high-resolution digital pathology images simultaneously. It supports diagnostic workflows through features like structured image analysis, annotation tools, and centralized management of pathology cases, all within a secure, cloud-hosted environment.