← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K954220

# EUB-8000 (K954220)

_Hitachi Medical Corp. of America · IYN · May 7, 1997 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K954220

## Device Facts

- **Applicant:** Hitachi Medical Corp. of America
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** May 7, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric

## Indications for Use

The Hitachi EUB-8000 Ultrasound Electronic Scanner is a Track 3 diagnostic ultrasound system capable of the following operating modes: B, M, Pulsed Doppler, Color Flow, and Continuous Wave Doppler. Probes available with the EUB-8000 are intended for the following general clinical uses: Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral Vascular, Biopsy, Transrectal, Transvaginal, and Neonatal Cephalic.

## Device Story

Hitachi EUB-8000 is a Track 3 diagnostic ultrasound system; utilizes digital front-end electronics for echo signal detection; supports B, M, Pulsed Doppler, Color Flow, and Continuous Wave Doppler modes. Used by clinicians for imaging across various anatomical regions including abdominal, cardiac, and fetal. System provides real-time acoustic output indices (thermal/mechanical) per NEMA UD-3 standards. Output aids clinicians in diagnostic assessment and clinical decision-making.

## Clinical Evidence

Bench testing only; compliance with NEMA UD-3 standard for real-time display of thermal and mechanical acoustic output indices and 1994 510(k) Diagnostic Ultrasound Guidance acoustic output limits.

## Technological Characteristics

Track 3 diagnostic ultrasound system; digital front-end electronics for signal detection; supports B, M, Pulsed Doppler, Color Flow, and Continuous Wave Doppler modes; complies with IEC 601-1 (1988) safety standards.

## Regulatory 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.

## Submission Summary (Full Text)

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K9074220

Revised April 28, 1997

MAY-7-1997

# ATTACHMENT 11

## SUMMARY OF SAFETY AND EFFECTIVENESS

Hitachi EUB-8000 Ultrasound Electronic Scanner

## Device Description

The Hitachi EUB-8000 Ultrasound Electronic Scanner is a Track 3 diagnostic ultrasound system capable of the following operating modes: B, M, Pulsed Doppler, Color Flow, and Continuous Wave Doppler. Probes available with the EUB-8000 are intended for the following general clinical uses: Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral Vascular, Biopsy, Transrectal, Transvaginal, and Neonatal Cephalic. The EUB-8000 utilizes digital front-end electronics for detection of echo signals.

## Safety

As a Track 3 ultrasound system, the Hitachi EUB-8000 Ultrasound Electronic Scanner complies with the "Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (1992), published by the National Electrical Manufacturers Association as UD-3. With respect to limits on acoustic outputs, the Hitachi EUB-8000 Ultrasound Electronic Scanner complies with the guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance.

With regard to general safety, the Hitachi EUB-8000 Ultrasound Electronic Scanner will be designed to comply with the IEC 601-1 (1988) Medical Electrical Equipment, Part 1, General Requirements for Safety.

05:17 /6-67-1dy

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K954220](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K954220)

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