FullFocus
by Paige.AI, Inc. EUDAMED510(k)
Active
510(k) K201005
Overview
FullFocus is a digital pathology image viewing and management software designed for the analysis and interpretation of histopathological slides. It integrates advanced computational pathology tools to assist pathologists in evaluating tissue samples, enhancing diagnostic accuracy and workflow efficiency in laboratory settings.
This software is supplied as a cloud-based or on-premise solution, intended for use in pathology laboratories and diagnostic centers. It operates under FDA 510(k) clearance and IVDR compliance, supporting single-user or multi-user configurations depending on the deployment model. The system requires compatible hardware and network connectivity, with no sterility or single-use considerations applicable. Authorisations include multiple registration numbers under the regulation 864.3700 for digital pathology applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK201005 | Date15 Jul 2020 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 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.
Questions
What types of pathology laboratories can use FullFocus, and how does it differ between cloud-based and on-premise deployment?
FullFocus is designed for pathology laboratories and diagnostic centers that analyze histopathological slides. The software offers two deployment options: cloud-based (accessible via network connectivity) and on-premise (installed locally on compatible hardware). The choice depends on your infrastructure needs—cloud-based solutions provide scalability and remote access, while on-premise deployments offer greater control over data security and local IT management. Both models support single-user or multi-user configurations, depending on the specific setup.
Is FullFocus intended for direct patient diagnosis, or is it primarily a tool for pathologists to assist with slide analysis?
FullFocus is not intended for direct patient diagnosis. Instead, it serves as a digital pathology image viewing and management software that assists pathologists by integrating computational tools to evaluate histopathological slides. Its purpose is to enhance diagnostic accuracy and workflow efficiency in laboratory settings, not to replace clinical judgment.
Does FullFocus require any special hardware or network setup, and are there compatibility considerations for integration?
Yes, FullFocus requires compatible hardware (such as high-resolution displays and sufficient processing power) and network connectivity for cloud-based use. For on-premise deployment, the system must be installed on servers or workstations meeting the manufacturer’s technical specifications. While no sterility or single-use considerations apply, compatibility with existing laboratory IT systems (e.g., PACS or LIS integration) may be necessary for seamless workflow adoption.
How does FullFocus ensure compliance with regulatory standards, and what does its FDA 510(k) clearance and IVDR compliance mean for users?
FullFocus holds FDA 510(k) clearance under the classification for digital pathology image viewing software, demonstrating it is substantially equivalent to a legally marketed predicate device. It also complies with the In Vitro Diagnostic Regulation (IVDR) in the EU, ensuring adherence to stringent quality and safety standards. For users, this means the software meets regulatory requirements for diagnostic assistance in pathology, though it does not imply approval for any specific clinical indication—only that it operates within established safety and performance guidelines.