Consult Station TS
by H4D Sas France EUDAMED510(k)
510(k) K153600 Product code DXN
Overview
The Consult Station TS is a diagnostic workstation designed for cardiovascular imaging and analysis, classified under the product code DXN. It integrates advanced imaging software and hardware to facilitate the evaluation of cardiac structures and functions, supporting clinical decision-making in cardiology.
This device is supplied as a reusable system intended for use in clinical settings such as hospitals or cardiac care units. It is not sterile and requires proper maintenance and calibration as per manufacturer guidelines. The Consult Station TS is authorised under FDA 510K clearance, MDD, and MDR compliance, ensuring adherence to regulatory standards for cardiovascular diagnostic equipment.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK153600 | Date17 Mar 2017 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Questions
What clinical specialties would benefit most from using the Consult Station TS in their workflows?
The Consult Station TS is specifically designed for cardiology departments, where it aids in the evaluation of cardiac structures and functions through advanced imaging and analysis. Clinicians in hospitals or cardiac care units can leverage its integrated software and hardware to support diagnostic decision-making, making it particularly useful for cardiologists, cardiac imaging specialists, and interventional cardiologists.
How is the Consult Station TS supplied, and what maintenance does it require?
The Consult Station TS is supplied as a reusable system, meaning it is not intended for single-use. It is meant for clinical settings like hospitals or cardiac care units, where it requires proper maintenance and calibration as outlined by the manufacturer. Since it is not sterile, it must be cleaned and serviced according to established protocols to ensure reliable performance and compliance with regulatory standards.
What regulatory pathways does the Consult Station TS follow, and how does this impact its use?
The Consult Station TS has been authorized through FDA 510(k) clearance, as well as compliance with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). This ensures it meets stringent regulatory requirements for cardiovascular diagnostic equipment, providing confidence in its safety, performance, and suitability for clinical use in cardiovascular imaging and analysis.
Is the Consult Station TS compatible with specific imaging modalities, or does it support multiple types of cardiovascular imaging?
While the Consult Station TS is described as a diagnostic workstation for cardiovascular imaging and analysis, the provided data does not specify exact imaging modalities it supports. However, its design suggests it integrates advanced software and hardware to evaluate cardiac structures and functions, implying broad compatibility with common cardiovascular imaging techniques such as echocardiography, CT, or MRI—though exact details would require consulting the manufacturer’s documentation.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K153600
- EUDAMED