6VT-D Ultrasound Transducer

510(k) Number

K141093 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• Ge Vscan Compact Diagnostic Ultrasound System

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• Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System Open recall

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  CE/MDR FDA 510(k) K150087 Active Cleared 4 Mar 2015 +1authorizations

• P2D

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  CE/MDR GUDID on market

• Vivid E95

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See all devices from GE Vingmed Ultrasound AS →

• What types of cardiac imaging can the 6VT-D Ultrasound Transducer provide, and why is this important for clinicians?

  The 6VT-D Ultrasound Transducer is designed for transesophageal echocardiography (TEE), offering multiplane imaging with a 90-degree field of view. This allows clinicians to visualize cardiac structures from multiple angles, improving diagnostic accuracy for conditions like valve disorders, structural heart disease, or intracardiac masses. Its electronic 4D capability further enhances precision by enabling volumetric data acquisition, which is critical for detailed assessments in complex cases.

• Is this device reusable, or does it require single-use disposal after each procedure, and what does that mean for infection control?

  The 6VT-D Ultrasound Transducer is intended for single-use only, meaning it must be discarded after a single procedure to ensure patient safety and infection control. This aligns with standard sterile medical device protocols, as it is sterile upon packaging and designed for clinical diagnostic settings where contamination risks must be minimized. Reuse is not supported by the manufacturer.

• What frequency range does this transducer operate within, and how does that affect image quality for cardiac imaging?

  The 6VT-D operates within a 3.0–8.0 MHz frequency range, which balances depth penetration (lower frequencies) and spatial resolution (higher frequencies). This range is ideal for transesophageal echocardiography, where clinicians need to visualize both shallow structures (like valves) and deeper cardiac chambers with clarity. The broader frequency spectrum also supports the 90-degree field of view and 4D volumetric imaging, enhancing diagnostic detail.

• How should this device be stored, and are there any special handling instructions beyond standard sterile device protocols?

  The 6VT-D should be stored following standard sterile medical device protocols, as it is sterile upon packaging. No additional storage conditions (like refrigeration or humidity control) are specified, but it must remain in its sealed packaging until use to preserve sterility. Unlike some devices, there are no MRI safety restrictions mentioned, meaning it can be used in MRI-compatible environments without interference concerns. Always check the packaging for expiration dates before use.

• What ultrasound systems is this transducer compatible with, and does it require any special connections or software?

  The 6VT-D is designed to connect to GE ultrasound systems exclusively, as it is a proprietary transducer for their imaging platforms. It does not require external energy delivery or specialized software—its functionality is passive and integrated into the GE system’s imaging capabilities. Compatibility is ensured through the manufacturer’s design specifications for TEE applications.