ImageGrid Radiology Viewer System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092949 FDA 510(k)
- FDA Product Code
- LLZ 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)
The ImageGrid Radiology Viewer System is a medical imaging device designed for the reception, storage, communication, and display of digital medical images and data from various imaging modalities. It functions as a Picture Archiving and Communication System (PACS) to facilitate workflow optimization, enabling radiologists and clinicians to view, analyze, and share images across distributed networks.
This system is supplied as software and integrates with existing IT infrastructure to route, store, and present DICOM-compatible medical images. It is intended for use in radiology departments and clinical settings, where pre-processed DICOM presentation images—including mammography—can be interpreted for diagnostic purposes. The device is classified under FDA 510(k) clearance (K092949) with a traditional review pathway and is intended for single-use or multi-user networked environments, though sterility and reuse specifications are not explicitly detailed in the data.
Frequently asked questions
What types of medical imaging data can the ImageGrid Radiology Viewer System display and analyze for diagnostic purposes?
The ImageGrid Radiology Viewer System is designed to handle and display DICOM-compatible medical images, including those from modalities like mammography and other radiology studies. It functions as a PACS (Picture Archiving and Communication System) to support workflow optimization, allowing radiologists and clinicians to interpret pre-processed diagnostic images across networked environments. The system routes, stores, and presents these images for analysis, ensuring seamless integration with existing IT infrastructure.
Is the ImageGrid Radiology Viewer System intended for single-user or multi-user environments, and how is it supplied?
The ImageGrid Radiology Viewer System is intended for both single-use and multi-user networked environments, meaning it can be deployed in settings where multiple users may access the system simultaneously. It is supplied as software rather than a physical device, requiring integration with an organization’s existing IT infrastructure to function. This software-based approach allows for scalability and flexibility in radiology departments or clinical settings.
How does the ImageGrid Radiology Viewer System support diagnostic workflows, and what kind of network compatibility does it require?
The ImageGrid Radiology Viewer System optimizes diagnostic workflows by enabling real-time reception, storage, communication, and display of digital medical images across distributed networks. Since it relies on DICOM-compatible imaging data, it integrates seamlessly with existing radiology IT systems to route images efficiently. This ensures radiologists and clinicians can view, analyze, and share diagnostic images—such as mammograms—without disruption, improving collaboration and reducing delays in interpretation.
Does the ImageGrid Radiology Viewer System require any specific storage or environmental conditions, and is it compatible with existing hospital IT systems?
The ImageGrid Radiology Viewer System is a software-based solution, meaning it does not have physical storage requirements like hardware-based systems. However, it requires integration with an organization’s existing IT infrastructure to function, including servers, networks, and DICOM-compatible imaging systems. While the data does not specify environmental storage conditions, typical IT infrastructure best practices (e.g., temperature, humidity, and secure access controls) should be followed to ensure optimal performance and data security.
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: Medical Imaging Solutions | Candelis, Candelis, Inc. Ig-7b-dr Imagegrid Radiology Viewer System, Candelis, Inc. Ig-uhp-r1b-dr Imagegrid Radiology Viewer System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092949 | Class II | Active |
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Manufacturer
- Manufacturer
- Candelis, Inc.
Sources (1)
- FDA 510(k) K092949 24 fields · synced Sep 19, 2026