Identifiers
- 510(k) Number
- K243647 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Synapse PACS 7.5 is a web-based Picture Archiving and Communication System (PACS) designed for managing, displaying, and processing medical images from multiple imaging modalities. It integrates advanced functionalities such as measurements, regional segmentation, 3D volume rendering, image fusion, and structured report generation to assist radiologists and cardiologists in image interpretation and diagnostic workflows.
This software is supplied as a digital solution, intended for use in radiology departments and clinical imaging settings. It is classified under the product code QIH and holds FDA 510(k) clearance (K243647) and MDR authorization. The system operates as a reusable software application, with no specified sterility or single-use requirements, and is compatible with standard radiology workflows. No MRI safety classifications or physical size specifications are provided.
Frequently asked questions
What types of medical images can the Synapse PACS 7.5 system handle, and how does it assist radiologists in their workflow?
The Synapse PACS 7.5 is designed to manage, display, and process medical images from multiple imaging modalities, including those commonly used in radiology and cardiology. It includes advanced features like measurements, regional segmentation, 3D volume rendering, image fusion, and structured report generation. These tools help radiologists and cardiologists improve diagnostic accuracy and efficiency by streamlining image interpretation and analysis within clinical workflows.
Is the Synapse PACS 7.5 a single-use or reusable system, and what does that mean for my facility?
The Synapse PACS 7.5 is a reusable software application, meaning it is installed and used repeatedly within a facility. Since it is a digital solution, there are no physical consumables or single-use components to replace. This makes it cost-effective for long-term use in radiology departments and clinical imaging settings, as updates and maintenance can be applied centrally without replacing the entire system.
How is the Synapse PACS 7.5 distributed or deployed in a healthcare setting?
The Synapse PACS 7.5 is supplied as a digital solution, meaning it is installed on servers or cloud infrastructure within your facility. It is not a physical device but rather a software platform that integrates with existing radiology workflows. The deployment typically involves installation on compatible hardware and network setup to ensure seamless access to medical imaging data across departments.
What regulatory pathways has the Synapse PACS 7.5 followed, and what does that mean for compliance in my facility?
The Synapse PACS 7.5 holds FDA 510(k) clearance (K243647) under the product code QIH, which indicates it is classified as substantially equivalent to a predicate device. It also holds MDR authorization, meaning it complies with European medical device regulations if applicable. This ensures the system meets U.S. and EU standards for safety and effectiveness, allowing your facility to use it confidently within radiology and clinical imaging settings.
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. Sources consulted: Synapse PACS (7.5) | FDA Radiology AI Device, Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation radiology ..., FUJIFILM Healthcare Americas Corporation: Synapse PACS (7.5) (FDA ..., Synapse PACS (7.5) | FDA Radiology AI Device
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243647 | Class II | Active |
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Manufacturer
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
Sources (2)
- FDA 510(k) K243647 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026