đź“‹ FDA Reference
Impax Orthopaedic Workstation Model Impax Es 5 x
Agfa
Summary: The Impax Orthopaedic Workstation Model Impax ES 5 X by Agfa is a medical imaging device used primarily by radiologists and orthopedic specialists for diagnostic purposes. It is designed to assist in the visualization and analysis of orthopedic conditions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K050751 ↗
Decision Date ?
April 21, 2005
Product Code ?
LLZ
Device Class ?
Class 2
Evidence ?
0 studies
The Impax Orthopaedic Workstation was cleared through the FDA 510(k) process on April 21, 2005, under product code LLZ. It is manufactured by Agfa and classified as a Class 2 medical device.
What It Is
The Impax Orthopaedic Workstation is a specialized imaging workstation designed to support orthopedic diagnostics. It integrates advanced imaging software to provide detailed visualizations of musculoskeletal structures. This device facilitates the analysis and interpretation of complex orthopedic images, aiding clinicians in making accurate diagnoses and treatment plans.
FDA-Cleared Indications
- For visualization and analysis of orthopedic images.
- For diagnostic review of musculoskeletal conditions, including bone and joint abnormalities.
Clinical Applications
- Reviewing orthopedic radiographic images for diagnostic assessment.
- Analyzing images of fractures and other bone abnormalities.
- Evaluating joint abnormalities and musculoskeletal disorders.
- Supporting orthopedic diagnostic decision-making and treatment planning.
Practical Considerations
- This is a software-based imaging workstation, not an implanted device or an imaging scanner.
- Compatibility depends on the facility’s imaging equipment, image formats, network configuration and software integration.
- The workstation should be operated by trained radiology or orthopedic personnel according to the applicable labeling and facility procedures.
- MRI safety applies to the MRI scanner and other equipment in the MRI environment; the workstation itself should be located and used according to site-specific electromagnetic-safety requirements.
- The FDA record identifies a Class II device cleared through the 510(k) pathway under product code LLZ; the record provided does not specify physical device sizes or a fixed service life.
Frequently Asked Questions
What is the Impax Orthopaedic Workstation used for?
It is used for visualizing and analyzing orthopedic conditions, aiding in the diagnosis and treatment planning of musculoskeletal disorders.
What specialties typically use this device?
Orthopedic surgeons and radiologists primarily use this device in clinical settings focused on musculoskeletal health.
What are the FDA-cleared indications?
The device is indicated for use in diagnostic imaging of orthopedic conditions, such as fractures and joint abnormalities, to assist in clinical decision-making.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.