ESI-5000

K935024 · Elscint, Inc. · IYN · Jun 12, 1996 · Radiology

Device Facts

• Record ID: K935024
• Device Name: ESI-5000
• Applicant: Elscint, Inc.
• Product Code: IYN · Radiology
• Decision Date: Jun 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended Use

The ESI-5000 ultrasound system main applications are in general radiology, obstetrics/gynecology, cardiology, and peripheral vessel 2D imaging, spectral Doppler analysis, and color Doppler Imaging.

Device Story

Multi-function real-time ultrasound imaging system; utilizes linear, curved, annular, and mechanical sector probes (3.5-10 MHz). Inputs: acoustic signals processed into 2D, M-mode, spectral Doppler, and color flow images. Used in clinical settings by trained medical professionals for diagnostic imaging. Output: visual display of anatomical structures and blood flow dynamics. Assists clinicians in diagnostic decision-making across radiology, OB/GYN, and cardiology. Complies with Track 3 acoustic output standards (SPTA 720 mW/cm2; SPPA 190 W/cm2) for fetal Doppler safety.

Clinical Evidence

Bench testing only. Compliance with acoustic output display standards and Track 3 intensity limits (SPTA 720 mW/cm2; SPPA 190 W/cm2) verified.

Technological Characteristics

Ultrasound imaging system; linear, curved, annular, and mechanical sector probes; 3.5-10 MHz frequency range. Modalities: 2D, M-mode, Spectral Pulsed/CW Doppler, Color Flow. Track 3 acoustic output compliance.

Indications for Use

Indicated for general radiology, obstetrics/gynecology, cardiology, and peripheral vessel imaging in patients requiring 2D, M-mode, spectral pulsed/CW Doppler, and color flow ultrasound assessment.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• ESI-1000 (Elscint Ltd.)
• ESI-2000 (Elscint Ltd.)
• ESI-3000 (Elscint Ltd.)
• 128 XP (Acuson)
• UM-9 (ATL)

Submission Summary (Full Text)

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5935024

JUN 12 1996

SUMMARY.

The ESI-5000 ultrasound system main applications are in general radiology, obstetrics/gynecology, cardiology, and peripheral vessel 2D imaging, spectral Doppler analysis, and color Doppler Imaging.

It is a multi function real time ultrasound imaging system, featuring 2D imaging, M mode, Spectral Pulsed and CW Doppler, and Color Flow, using a variety of linear array, curved array, annular array, and mechanical sector probes, in the frequency range of 3.5 MHz. to 10 MHz.

Regarding safety and effectiveness, the main features of the ESI-5000 are compared to the main features of the following predicate ultrasound systems:

ESI-1000 manufactured by Elscint Ltd.

ESI-2000 manufactured by Elscint Ltd.

ESI-3000 manufactured by Elscint Ltd.

128 XP manufactured by Acuson.

UM-9 manufactured by ATL.

Acoustic output compliance:

Since the ESI-5000 includes "Fetal Doppler" examination capabilities, the ultrasound system-transducer combination conforms with the output display standard, and is designed to comply with the maximum intensity levels for track 3:

The absolute maximum intensity is limited to SPTA=720 mW/cm2, and SPPA=190 W/cm2. In addition the intensity is limited to the operator selected, application specific limit, which is always below the allowed absolute maximum.