Echoview Shimasonic Diagnostic Ultrasound System, Model SDU-2200PRO

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

510(k) Number

K061637 ↗

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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  Class II

  FDA 510(k) K973802 Active Cleared 4 Mar 1998

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  Class II

  FDA 510(k) K955255 Active Cleared 9 Feb 1996

• Shimadzu X-Ray High-Voltage Generator XUD150K

  Class I

  FDA 510(k) K911339 Active Cleared 16 Apr 1991

• Shimadzu X-Ray High-Voltage Generator XUD150B

  Class I

  FDA 510(k) K911280 Active Cleared 17 Jun 1991

• Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-7000TX W/Fluro Option

  Class II

  FDA 510(k) K984156 Active Cleared 21 Apr 1999

• MU125M Mobile X-Ray System

  Class II

  FDA 510(k) K920393 Active Cleared 6 Apr 1992

See all devices from Shimadzu Medical Systems →

• What clinical applications does the Shimadzu SDU-2200PRO ultrasound system support?

  The Shimadzu SDU-2200PRO ultrasound system is designed for diagnostic imaging in clinical settings. It supports multiple imaging modes, including B-mode for anatomical structure visualization, M-mode for motion assessment, and Doppler techniques (Pulsed, Continuous, Color, and Tissue Harmonic Imaging) to evaluate blood flow. These capabilities make it suitable for assessing organs, vascular systems, and other soft tissues in real-time.

• Is the Shimadzu SDU-2200PRO ultrasound system reusable or single-use?

  The Shimadzu SDU-2200PRO is supplied as a reusable device. Unlike single-use systems, it is intended for repeated use in clinical environments, though proper cleaning and maintenance protocols must be followed to ensure reliability and safety. There are no sterility requirements specified for this model.

• What types of probes does the Shimadzu SDU-2200PRO support, and what frequency ranges do they cover?

  The Shimadzu SDU-2200PRO supports three types of probes: linear array, convex, and sector probes. These probes operate across a frequency range of 2-15 MHz, allowing for versatile imaging applications depending on the clinical need, such as superficial or deep tissue evaluation.

• What regulatory pathway was followed for the Shimadzu SDU-2200PRO ultrasound system?

  The Shimadzu SDU-2200PRO received a Substantially Equivalent determination through the Traditional 510(k) pathway, as classified under the FDA product code IYN (892.1550). This classification pertains to radiology imaging systems, and the device adheres to FDA regulatory standards for diagnostic ultrasound systems.

• Are there any special storage or handling requirements for the Shimadzu SDU-2200PRO?

  The provided specifications do not specify any special MRI safety or storage conditions for the Shimadzu SDU-2200PRO. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight and extreme temperatures to maintain its functionality and longevity. Standard maintenance procedures should also be followed.