Forum Archive & Viewer Forum Assist Match
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122938 FDA 510(k)
- FDA Product Code
- NFJ 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 Forum Archive & Viewer Forum Assist Match is a client-server software system for ophthalmic image and data management, classified as an Image Management System for ophthalmic use. It facilitates the storage, retrieval, and consolidation of diagnostic data—including images, videos, reports, and raw data—from networked ophthalmic instruments via DICOM interface. The system ensures organized archival of patient records while supporting efficient data retrieval for clinical review.
This software is designed for use in ophthalmic clinical settings, operating as a standalone application compatible with Forum Archive or Viewer versions 4.2 or higher. It is supplied as a non-sterile, reusable digital solution with no regulatory restrictions on MRI safety. The device holds FDA 510(k) clearance (K122938) under the Radiology (OP) Advisory Committee, classified as Class II. No single-use or sterility requirements apply, as it is intended for institutional deployment on networked PCs.
Frequently asked questions
What is the Forum Assist Match Archive & Viewer used for?
The Forum Assist Match Archive & Viewer is a client-server software system designed specifically for ophthalmic image and data management. It consolidates diagnostic data—such as images, videos, reports, and raw data—from networked ophthalmic instruments via the DICOM interface. This allows clinicians to store patient records systematically and retrieve them efficiently for review, improving workflow and record organization in ophthalmic settings.
How is the Forum Assist Match Archive & Viewer supplied and deployed?
This software is supplied as a standalone digital solution, compatible with Forum Archive or Viewer versions 4.2 or higher. It is intended for institutional deployment on networked PCs, meaning it requires installation on a hospital or clinic’s internal network rather than as a standalone device. No physical hardware is included; it operates entirely as a software application.
Is the Forum Assist Match Archive & Viewer sterile or single-use?
The Forum Assist Match Archive & Viewer is neither sterile nor single-use. As a digital software system, it is designed for reusable institutional deployment on networked computers. Sterility and single-use requirements do not apply, as the device interacts with patient data rather than physical patient contact.
What are the key specifications or requirements for using this software?
The software requires compatibility with Forum Archive or Viewer versions 4.2 or higher and must be installed on networked PCs within an ophthalmic clinical setting. It connects to ophthalmic instruments via the DICOM interface to manage diagnostic data. No regulatory restrictions apply regarding MRI safety, as it is a non-physical, digital solution. The system is classified as Class II under FDA 510(k) clearance (K122938).
How does the Forum Assist Match Archive & Viewer ensure data security and organization?
The system organizes and archives patient records by consolidating diagnostic data from multiple ophthalmic instruments into a centralized database. This allows for efficient retrieval of images, videos, and reports, reducing manual search time and improving clinical workflow. The DICOM interface ensures compatibility with existing ophthalmic devices, while the software’s networked architecture supports institutional deployment for long-term data management.
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: FORUM ophthalmology software - ZEISS Vision Care, PDF FORUM ASSIST match from ZEISS, PDF FORUM ASSIST match von ZEISS, Forum Forum Archive Forum Archive & Viewer Forum Assist Match
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122938 | Class II | Active |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
- FDA Applicant
- Carl Zeiss Meditec, AG
Sources (1)
- FDA 510(k) K122938 24 fields · synced Oct 5, 2026