CASE Cardiac Testing System
by Ge Medical Systems Information Technologies GmbH
510(k) K103678
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK103678 | Date16 Feb 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Case Cardiac Testing System, Cs Cardiac Testing System
- 510(k) Number
- FDA product code
- DQK
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The CASE Cardiac Testing System is a diagnostic device classified as a Cardiac Stress Testing System (Product Code: DQK). It is designed to perform resting electrocardiogram (ECG), exercise stress testing, spirometry, and ambulatory blood pressure monitoring. The system also enables real-time ECG recording with optional arrhythmia detection, facilitating comprehensive cardiac assessment during physical exertion.
This device is intended for use in clinical settings, including hospitals and cardiac care facilities. Supplied as a reusable system, it requires proper calibration and maintenance to ensure accurate diagnostic results. The CASE Cardiac Testing System holds FDA 510(k) clearance (K103678) under the Traditional pathway, with a decision date of February 16, 2011. No specific sterility or MRI safety information is provided in the regulatory data.
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Questions
AI-generated answers, 1 Oct 2026
What clinical applications does the CASE Cardiac Testing System support?
The CASE Cardiac Testing System is designed for resting electrocardiogram (ECG) evaluation, exercise stress testing, spirometry, and ambulatory blood pressure monitoring. These features enable clinicians to assess cardiac function during physical exertion, detect arrhythmias in real-time, and monitor respiratory health, making it ideal for comprehensive cardiac and pulmonary evaluations in hospitals and cardiac care facilities.
Is the CASE Cardiac Testing System single-use or reusable?
The CASE Cardiac Testing System is supplied as a reusable device. To maintain accuracy and reliability, it requires proper calibration and regular maintenance as part of its operational workflow in clinical settings.
What regulatory pathway was followed for FDA clearance?
The CASE Cardiac Testing System received FDA 510(k) clearance (K103678) under the Traditional pathway, with the Cardiovascular (CV) Advisory Committee providing review. The decision date was February 16, 2011, confirming its substantial equivalence to a predicate device.
Does the system include optional arrhythmia detection?
Yes, the CASE Cardiac Testing System features optional arrhythmia detection as part of its real-time ECG recording capabilities. This functionality allows clinicians to identify irregular heart rhythms during exercise stress testing, enhancing diagnostic precision.
What type of clinical environments is this system intended for?
The CASE Cardiac Testing System is intended for use in structured clinical settings such as hospitals and specialized cardiac care facilities. Its comprehensive diagnostic tools support detailed cardiac assessments, making it suitable for environments where stress testing and respiratory monitoring are standard procedures.