ESI-3000 Ultrasound System

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

510(k) Number

K904359 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Gyrex 2T Prestige Model No. 100-6321-0107 and Gyrex Privilege Model No. 100-6326-0102

  Class II

  FDA 510(k) K965044 Active Cleared 16 Jun 1997

• Head and Neck Coil for the Gyrex 2T-Dlx

  Class II

  FDA 510(k) K943320 Active Cleared 29 Nov 1994

• Dynex-44 Diagnostic Ultrasound Imaging

  Class II

  FDA 510(k) K812014 Active Cleared 16 Sep 1981

• Gyrex Privilege

  Class II

  FDA 510(k) K954039 Active Cleared 24 Nov 1995

• 2T Prestige(100-6321-0107)/Privilege(100-6326-0102)/Gyrex V-Ep(100-6327-0101)

  Class II

  FDA 510(k) K972592 Active Cleared 15 Sep 1997

• Ultrasound Equipment Model Sdl-100A

  Not classified

  FDA 510(k) K837084 Active Cleared 28 Apr 1983

See all devices from Elscint, Inc. →

• What clinical settings or specialties would typically use the ESI-3000 Ultrasound System, and why is it suited for those environments?

  The ESI-3000 Ultrasound System is primarily designed for use in radiology departments, where it enables real-time imaging of internal body structures like organs, tissues, and blood flow. Clinicians in specialties such as obstetrics, cardiology, abdominal imaging, and vascular studies would find it useful due to its capability to provide diagnostic visualizations without ionizing radiation, making it versatile for a wide range of patient evaluations.

• Is the ESI-3000 Ultrasound System intended for single-use or reusable applications, and what considerations should be taken into account?

  The ESI-3000 Ultrasound System is classified for both single-use and reusable applications, depending on facility protocols and infection control practices. Since no specific sterility information is provided, facilities must follow standard medical device reprocessing guidelines if reusing the device. Proper cleaning, disinfection, and maintenance are critical to ensure safety and performance, especially in clinical settings where multiple patients are evaluated.

• How should the ESI-3000 Ultrasound System be stored, and are there any special handling instructions mentioned in the available data?

  The ESI-3000 Ultrasound System follows general medical device storage guidelines, though no device-specific instructions are provided. It should be stored in a clean, dry environment protected from extreme temperatures, moisture, and physical damage. If reusable, storage should comply with facility protocols to maintain sterility and functionality, particularly if the device is shared across multiple patients or procedures.

• What regulatory pathway was followed for the FDA clearance of the ESI-3000 Ultrasound System, and what does this mean for its use in clinical practice?

  The ESI-3000 Ultrasound System received FDA 510(k) clearance under K-number K904359 through a traditional review process, with the Radiology (RA) advisory committee providing input. This clearance indicates the device was deemed substantially equivalent to a legally marketed predicate device, meaning it meets established safety and effectiveness standards for ultrasound imaging systems. Clinicians can rely on this approval as a basis for its use in diagnostic imaging within radiology departments.