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Cardiac Workstation (5000); Cardiac Workstation (7000)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241556

by Philips Medizin Systeme Böblingen GmbH

Identifiers

510(k) Number
K241556 FDA 510(k)
FDA Product Code
DPS FDA 510(k)
Models / Variants
Cardiac Workstation (5000) FDA 510(k)EUDAMED
Cardiac Workstation (7000) FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cardiac Workstation (5000) and (7000) are integrated diagnostic systems designed for cardiac imaging and analysis. These devices combine electrocardiogram (ECG), echocardiography, and other cardiac monitoring modalities to provide comprehensive assessments of cardiac function, structure, and pathology. They are classified under the product code DPS, reflecting their role in cardiovascular diagnostics and procedural support.

The workstations are intended for use in clinical settings such as hospitals and cardiac care units, supporting real-time imaging, data acquisition, and diagnostic reporting. Supplied as reusable medical equipment, they require proper maintenance and calibration to ensure accuracy and reliability. Both models are authorized under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), adhering to stringent regulatory standards for cardiovascular diagnostic devices.

Frequently asked questions

What clinical settings and procedures does the Cardiac Workstation support, and how does it integrate different diagnostic tools?

The Cardiac Workstation (5000 and 7000) is designed for use in hospitals and cardiac care units, where it combines electrocardiogram (ECG) and echocardiography into a single system. This integration allows clinicians to perform real-time cardiac imaging and monitoring, enabling comprehensive assessments of heart function, structure, and potential pathologies. The device supports diagnostic workflows by providing simultaneous data acquisition and analysis, improving efficiency in evaluating patients with cardiovascular concerns.

Are the Cardiac Workstation models reusable, and what maintenance is required to ensure their accuracy?

Yes, the Cardiac Workstation (5000 and 7000) are supplied as reusable medical devices. To maintain their accuracy and reliability, they require regular maintenance and calibration as part of standard operating procedures. Proper upkeep ensures consistent performance for cardiac imaging and diagnostic reporting in clinical settings.

What regulatory pathways have the Cardiac Workstation models followed, and how does this affect their use?

The Cardiac Workstation (5000 and 7000) have undergone FDA 510(k) clearance and comply with the EU Medical Device Regulation (MDR). These pathways confirm that the devices meet stringent regulatory standards for cardiovascular diagnostic equipment, ensuring their safety, performance, and suitability for use in clinical environments like hospitals and cardiac care units.

How do the two models, (5000) and (7000), differ in terms of their intended use or capabilities?

While the exact technical differences between the Cardiac Workstation (5000) and (7000) are not detailed in the provided data, both models are described as integrated diagnostic systems for cardiac imaging and analysis. Their classification under product code DPS indicates they serve similar roles in cardiovascular diagnostics and procedural support. Any distinctions would likely lie in performance specifications, software features, or scalability for different clinical workflows, but the core purpose remains consistent—comprehensive cardiac assessment.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medizin Systeme Böblingen GmbH

Sources (2)

  • FDA 510(k) K241556 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026