Cardiac Workstation (5000); Cardiac Workstation (7000)
Philips Medizin Systeme Böblingen GmbHThe Cardiac Workstation 5000 and 7000 by Philips Medizin Systeme Böblingen GmbH are advanced electrocardiograph devices designed for healthcare professionals to acquire, analyze, and store multi-channel ECG signals from adult and pediatric patients. These devices use clinically proven algorithms to provide measurements, graphical presentations, and interpretive statements to support clinical decision-making in hospitals and cardiology clinics.
Intended Use
The Cardiac Workstation is intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes, and to record, display, analyze and store these ECG signals for review by the user in healthcare facilities by trained professionals.
Technology
The device combines a mid- to high-range interpretive cardiograph with integrated display and printer, powered by Linux OS, touchscreen interface, and the Philips DXL ECG Algorithm for analysis of up to 18-lead ECG signals including rhythm and morphology. It supports configurations for clinical settings and has security enhancements including encryption and authentication.
Performance
The devices passed comprehensive non-clinical tests covering safety, electromagnetic compatibility, cybersecurity, software and hardware performance, usability, and reliability. No clinical studies were required. Performance and safety are substantially equivalent to the legally marketed predicate device (K210560).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/31/2024
6 months - 2
FDA Approval
12/17/2024
Other devices from Philips Medizin Systeme Böblingen GmbH
- Philips Holter Analysis System2025 • 510K
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