Echo View/Shimasonic Diagnostic Ultrasound System, Model SDU-2200

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

510(k) Number

K003514 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Shimasonic Linear/Convex Diagnostic Ultrasound System

  Class II

  FDA 510(k) K973802 Active Cleared 4 Mar 1998

• Shimadzu Whole Body X-Ray CT Scanner Sct-7000TX

  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 is the Echo View/Shimasonic Diagnostic Ultrasound System used for?

  The Echo View/Shimasonic Diagnostic Ultrasound System, Model SDU-2200 is designed for medical imaging purposes, specifically for diagnostic applications in radiology.

• How is the Echo View/Shimasonic Diagnostic Ultrasound System supplied?

  The system is supplied as a complete unit and requires appropriate storage conditions as specified by the manufacturer.

• What regulatory status does the Echo View/Shimasonic Diagnostic Ultrasound System have?

  The device received FDA 510(k) clearance with K003514 on February 12, 2001, and is classified as a Class II device under product code IYN.

• What is the intended use setting for the Echo View/Shimasonic Diagnostic Ultrasound System?

  The system is intended for use in clinical settings for diagnostic ultrasound imaging applications.