Identifiers
- 510(k) Number
- K151780 FDA 510(k)
- FDA Product Code
- IZI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1600 FDA 510(k)
- Regulation Number
- 892.1600 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CAAS Workstation is a System, X-Ray, Angiographic device designed for quantitative coronary and peripheral artery analysis, ventricular function assessment, and stent visualization. It integrates angiography with intravascular imaging modalities, such as IVUS and OCT pullbacks, to enhance diagnostic accuracy in cardiovascular evaluations.
This device is intended for use in cathlab and research settings, featuring a flexible graphical user interface (GUI) for customizable workflows. Supplied as a reusable system, it adheres to DICOM standards for image compatibility and has received FDA 510K clearance under the Medical Devices Directive (MDD). Authorized under regulation number 892.1600, it operates within Class II regulatory classification.
Frequently asked questions
What clinical applications is the CAAS Workstation primarily designed for in a cathlab setting?
The CAAS Workstation is designed for quantitative coronary and peripheral artery analysis, ventricular function assessment, and stent visualization. It integrates angiography with intravascular imaging modalities like IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography) pullbacks to improve diagnostic accuracy in cardiovascular evaluations.
Is the CAAS Workstation reusable or single-use, and how does this affect its maintenance?
The CAAS Workstation is supplied as a reusable system, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. This design requires adherence to facility protocols for sterilization and upkeep to ensure consistent performance and compliance with regulatory standards.
What types of imaging modalities does the CAAS Workstation integrate with, and how does this enhance diagnostics?
The CAAS Workstation integrates angiography with intravascular imaging modalities such as IVUS and OCT pullbacks. This combination allows for more detailed and accurate assessments of coronary and peripheral arteries, ventricular function, and stent placement, improving diagnostic precision in cardiovascular procedures.
What regulatory pathways has the CAAS Workstation followed, and what does this mean for its use in clinical settings?
The CAAS Workstation has received FDA 510K clearance under the Medical Devices Directive (MDD) and is authorized under regulation number 892.1600, classified as a Class II device. This means it has undergone evaluation by the FDA’s Radiology Advisory Committee (RA) and is deemed substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for use in cathlab and research settings.
How does the CAAS Workstation’s flexible graphical user interface (GUI) benefit users in a cathlab?
The CAAS Workstation features a flexible GUI that allows for customizable workflows, enabling clinicians to tailor the system to their specific diagnostic needs. This adaptability enhances efficiency and user experience, particularly in complex procedures where precise and personalized imaging analysis is required.
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: Caas Workstation - Pie Medical Imaging, Pie Medical Imaging - Solutions in cardiovascular analysis, PDF CAAS Workstation DICOM Conformance Statement - medical.canon
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K151780 | Class II | Active |
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Manufacturer
- Manufacturer
- Pie Medical Imaging BV
Sources (2)
- FDA 510(k) K151780 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026