Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Erad, Inc.
Identity
- Trade Name
- eRAD Viewer EUDAMED
- Device Name
- eRAD Viewer EUDAMED
- Model / Reference
- 9.y.z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860014963742 EUDAMED
- Basic UDI-DI
- 08600149637ViewerXR EUDAMED
- 510(k) Number
- K120995 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
- EMDN Code
- Z119082 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The ERAD PACS/RIS/PACS ERAD EPVLITE Viewer Software is a radiology information system (RIS) and picture archiving and communication system (PACS) viewer software designed for managing, storing, and displaying medical imaging data. It integrates with existing PACS and RIS platforms to facilitate efficient retrieval, review, and analysis of digital radiographic images and related patient information.
This software is supplied as a digital product for use in radiology departments, hospitals, or clinical imaging centers, where it operates on compatible IT infrastructure. It is intended for single-use in a networked environment, with no explicit sterility or reusable requirements. The system adheres to FDA 510(k) clearance under K120995 and EU MDR compliance, ensuring alignment with regulatory standards for medical imaging software. No MRI safety classifications or physical size specifications are provided.
Frequently asked questions
What types of medical imaging data can the ERAD EPVLITE Viewer Software handle and how does it integrate with existing systems?
The ERAD EPVLITE Viewer Software is designed to manage, store, and display digital radiographic images alongside related patient information. It integrates with existing PACS (Picture Archiving and Communication System) and RIS (Radiology Information System) platforms, allowing radiology departments, hospitals, or clinical imaging centers to efficiently retrieve, review, and analyze these images in a networked environment. The software acts as a viewer and does not require physical hardware beyond compatible IT infrastructure.
Is the ERAD EPVLITE Viewer Software intended for single-use or reusable applications, and does it have any sterility requirements?
The ERAD EPVLITE Viewer Software is not a physical device and is intended for single-use in a networked environment, meaning it operates within a digital system rather than being consumed or discarded like a disposable medical device. Since it is software-based, there are no sterility requirements—it does not come in sterile packaging or require sterilization procedures.
What regulatory pathways does the ERAD EPVLITE Viewer Software follow, and how does it ensure compliance with medical imaging standards?
The software is cleared under the FDA 510(k) pathway with clearance number K120995, classified as *Substantially Equivalent* under the Radiology product code (LLZ) and reviewed by the Radiological Devices Advisory Committee (RA). It also complies with the EU Medical Device Regulation (MDR), ensuring alignment with both U.S. and European medical imaging software standards. These pathways confirm its safety and performance for managing digital radiographic images in clinical settings.
How is the ERAD EPVLITE Viewer Software supplied, and what infrastructure does it require for operation?
The software is supplied as a digital product, meaning it is distributed electronically rather than as physical hardware. To operate, it requires compatible IT infrastructure within radiology departments, hospitals, or clinical imaging centers. This includes existing PACS/RIS systems to which it integrates, allowing seamless retrieval and display of digital radiographic images without additional hardware dependencies.
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
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 | K120995 | Class II | Active |
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Manufacturer
- Manufacturer
- Erad, Inc.
Sources (2)
- FDA 510(k) K120995 24 fields · synced Sep 18, 2026
- EUDAMED cd0e026c-f071-4b35-9526-0e497fa1f2b5 61 fields · synced Jul 25, 2026