Orthopedic Software for Impax Workstations
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071972 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)
This software is a radiological image processing tool designed for orthopedic applications, integrated into the Impax Workstation platform. It enables the acquisition, digital processing, review, transfer, storage, archiving, and printing of medical images and associated patient demographic data. The software is classified under the radiology device category and supports diagnostic workflows for physicians.
The software is supplied as a standalone module for use with Agfa’s Impax Workstations and is intended for single-use in clinical settings. It requires no sterilization or reprocessing, as it operates digitally without physical contact with patients. The device holds FDA 510(k) clearance (K071972) under the Radiology Advisory Committee, with no specific MRI safety or sterility requirements stated. Storage and use adhere to standard IT and radiology department protocols.
Frequently asked questions
What is the Agfa Orthopedic Software for Impax Workstations used for?
This software is designed as a radiological image processing tool specifically for orthopedic applications. It integrates with Agfa’s Impax Workstations to handle the acquisition, digital processing, review, transfer, storage, archiving, and printing of medical images and patient data. It supports diagnostic workflows by streamlining the handling of orthopedic imaging for physicians.
How is the Agfa Orthopedic Software for Impax Workstations supplied and used?
The software is supplied as a standalone module exclusively for use with Agfa’s Impax Workstations. Since it operates digitally without physical contact with patients, it is intended for single-use in clinical settings. No sterilization or reprocessing is required, as it functions entirely within the IT environment of the radiology department.
Does the Agfa Orthopedic Software for Impax Workstations require sterilization or reprocessing?
No, the software does not require sterilization or reprocessing. It is a digital tool that operates within the Impax Workstation platform, meaning it has no physical components that come into contact with patients or require cleaning or disinfection procedures.
What regulatory clearance does the Agfa Orthopedic Software for Impax Workstations hold?
The software holds FDA 510(k) clearance under the Radiology Advisory Committee, with the clearance number K071972. This classification confirms it is substantially equivalent to a predicate device and adheres to radiology device standards without specific MRI safety or sterility requirements.
How should the Agfa Orthopedic Software for Impax Workstations be stored and maintained?
Storage and use of the software follow standard IT and radiology department protocols. Since it is a digital module, it should be maintained in accordance with the manufacturer’s guidelines for software updates, system compatibility, and data security within the Impax Workstation environment.
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: ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS (K071972) — FDA 510 (k ..., Agfa IMPAX Orthopaedic Application Orthopedic Planning Software User's ..., PDF ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS 510(k)… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071972 | Class II | Active |
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Manufacturer
- Manufacturer
- Agfa Healthcare Corp.
Sources (1)
- FDA 510(k) K071972 24 fields · synced Oct 1, 2026