Vivid T9/Vivid T8

The Vivid T9/Vivid T8 is a mobile diagnostic ultrasound system cleared by the FDA for cardiac, vascular, and general radiology applications based on its substantial equivalence to predicate devices. Its core technology utilizes digital acquisition and processing, with non-clinical tests validating its safety, biocompatibility, and compliance with medical device standards.

The U.S. Food & Drug Administration has determined that the Vivid T9/Vivid T8 diagnostic ultrasound system, manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC, is substantially equivalent to legally marketed predicate devices for its stated indications for use. This allows the company to market the Class II device, which is regulated as an Ultrasonic Pulsed Doppler Imaging System under specific product codes. The device's clearance is subject to general controls provisions of federal regulations, including requirements for annual registration, device listing, good manufacturing practices, and truthful labeling. Manufacturers must also comply with quality system regulations and other federal statutes, with additional guidance provided for any future changes to the device or its software that might require further review. The Vivid T9/Vivid T8 is a versatile, mobile diagnostic ultrasound system designed primarily for cardiac imaging and analysis, though it also supports vascular and general radiology applications. It features digital acquisition, processing, analysis, and display capabilities, with a user interface including an LCD monitor, touch panel, and various transducers. Intended for use by qualified healthcare professionals in a range of clinical environments such as hospitals and private offices, the system supports numerous clinical applications and operating modes. The determination of substantial equivalence was based on the device's shared fundamental technology with its predicate, with key differences including the addition of 'Vascular Access' as an indication for use, enhanced software features like image processing and remote viewing, and new accessories. Comprehensive non-clinical tests confirmed its acoustic output, biocompatibility, safety, and compliance with applicable medical device standards, negating the need for clinical studies.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific enhanced software features beyond "image processing and remote viewing" were added, and how do they quantitatively improve diagnostic capabilities?; Given the addition of 'Vascular Access' as an indication for use, what specific non-clinical test results supported its efficacy and safety for this new application?; How does the "shared fundamental technology" with predicate devices translate into specific performance metrics, such as image resolution, frame rate, or penetration depth, for the Vivid T9/T8?; Are there any post-market surveillance plans or real-world data collection efforts outlined to monitor the long-term performance and safety of the Vivid T9/T8 in various clinical settings?; What are the implications for clinicians regarding the user interface, particularly the "LCD monitor, touch panel, and various transducers," in terms of workflow efficiency and ease of use compared to predicate devices?