Additional Features ESI-3000 Ultrasound Unit

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

510(k) Number

K925627 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

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 is the ESI-3000 Ultrasound Unit used for?

  The ESI-3000 Ultrasound Unit is designed for use in radiology departments to provide diagnostic imaging capabilities. It is a complete ultrasound system intended for clinical settings to assist in medical imaging procedures.

• How is the ESI-3000 Ultrasound Unit supplied?

  The device is supplied as a complete ultrasound unit, ready for use in clinical environments. It includes all necessary components for diagnostic imaging procedures in radiology departments.

• What is the regulatory status of the ESI-3000 Ultrasound Unit?

  The ESI-3000 Ultrasound Unit is authorized under FDA 510(k) clearance K925627, which was issued on October 8, 1993. It is classified as a Class II medical device with product code IYO and was determined to be substantially equivalent to predicate devices.

• Is the ESI-3000 Ultrasound Unit reusable or single-use?

  The device information does not specify whether the ESI-3000 Ultrasound Unit is designed for single-use or multiple reuse. As a complete ultrasound system, it appears to be intended for repeated clinical use rather than disposable application.