Nicolet EME Legend TC22

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K993939 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Nicolet Biomedical, Inc. →

• What is the primary use of the Nicolet EME Legend TC22?

  The Nicolet EME Legend TC22 is designed for non-invasive vascular assessments, allowing clinicians to evaluate blood flow dynamics using ultrasound technology. It transmits ultrasound waves into the body to measure circulatory parameters in clinical settings, such as blood flow velocity and direction, which are critical for diagnosing vascular conditions.

• How is the Nicolet EME Legend TC22 supplied and intended for use?

  The Legend TC22 is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical environments after proper cleaning, disinfection, and maintenance. It is not classified as a single-use or sterile device, so it must be handled according to standard reusable medical equipment protocols to ensure safety and functionality.

• What transducer frequencies does the Nicolet EME Legend TC22 support?

  The device supports transducers with three distinct frequencies: 2 MHz, 4 MHz, and 8 MHz. These frequencies allow clinicians to select the appropriate probe for different depths and resolutions of vascular structures, optimizing the assessment of blood flow in various anatomical locations.

• Does the Legend TC22 operate in specific Doppler modes, and what are their purposes?

  Yes, the Legend TC22 operates in two Doppler modes: Pulsed Wave (PWD) and Continuous Wave (CWD). PWD provides detailed blood flow information at specific locations within vessels, while CWD measures high-velocity flow over a broader area, making it useful for assessing turbulent or high-speed blood flow conditions.

• What regulatory pathway does the Nicolet EME Legend TC22 follow?

  The Legend TC22 follows the FDA 510(k) clearance pathway under the Radiology Advisory Committee, with a clearance number of K993939. It is classified as a Class II – Special Controls device, meaning it has additional regulatory requirements to ensure its safety and effectiveness for vascular assessments.