Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
GE Medical Systems Information Technologies, Inc.Mac-Lab (AltiX AI.i), CardioLab (AltiX AI.i), ComboLab (AltiX AI.i), and MLCL Client Software (AltiX AI.i) are hemodynamic and electrophysiology recording systems developed by GE Healthcare. These systems record and display physiological data during cardiovascular procedures, allowing clinicians to analyze hemodynamic and electrophysiology signals in real time. The MLCL Client Software allows additional data analysis and remote viewing. These tools help doctors monitor and analyze patients' cardiovascular function during interventional procedures.
Intended Use
Systems are indicated for use on patients of all ages when a physician determines benefit from hemodynamic and electrophysiology procedures to record, display, and transmit physiological data for clinical use.
Technology
The devices record, display, and process real-time hemodynamic and electrophysiology data using signal filtering, amplification, digitization, and custom analysis techniques. They support multiple inputs and provide video distribution and network data transmission functionalities.
Performance
Non-clinical testing demonstrated conformance to multiple IEC standards for safety and functionality, with extensive software and system verification and validation. No clinical studies were needed to demonstrate substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/15/2024
27 days - 2
FDA Approval
12/12/2024
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