← Product Code [IYO](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO) · K962308

# EUB-905 (K962308)

_Hitachi Medical Corp. of America · IYO · Jul 17, 1996 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K962308

## Device Facts

- **Applicant:** Hitachi Medical Corp. of America
- **Product Code:** [IYO](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO.md)
- **Decision Date:** Jul 17, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1560
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric

## Indications for Use

The Hitachi EUB-905 Ultrasound Electronic Scanner is Track1 diagnostic ultrasound system capable of the following operating modes: B, B/M and M mode. Probes available with the EUB-905 are intended for the following general clinical uses: Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small organ, Peripheral Vascular, Transrectal and Transvaginal.

## Device Story

Diagnostic ultrasound system; operates in B, B/M, and M modes. Uses electronic scanning probes to acquire anatomical images. Used in clinical settings by trained healthcare professionals. Output displayed on monitor for real-time visualization of internal structures. Assists clinicians in diagnostic assessment of abdominal, cardiac, fetal, and vascular conditions. Benefits include non-invasive visualization of internal anatomy.

## Clinical Evidence

Bench testing only; compliance with acoustic output guidelines and IEC 601-1 safety standards.

## Technological Characteristics

Track1 diagnostic ultrasound system; B, B/M, and M modes; electronic scanning; complies with IEC 601-1 (1988) safety standards.

## Regulatory Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

## Submission Summary (Full Text)

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K962308

Hitachi EUB-905 Ultrasound Electronic Scanner
June 29, 1996
Attachment 11
Page 1
JUL 17 1996

# ATTACHMENT 11

## SUMMARY OF SAFETY AND EFFECTIVENESS
Hitachi EUB-905 Ultrasound Electronic Scanner

### Device Description

The Hitachi EUB-905 Ultrasound Electronic Scanner is Track1 diagnostic ultrasound system capable of the following operating modes: B, B/M and M mode. Probes available with the EUB-905 are intended for the following general clinical uses: Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small organ, Peripheral Vascular, Transrectal and Transvaginal.

### Safety

With respect to limits on acoustic outputs, the Hitachi EUB-905 Ultrasound Electronic Scanner comply with the guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance as a Track1 ultrasound system.

With regard to general safety, the Hitachi EUB-905 Ultrasound Electronic Scanner is designed to comply with the international standards IEC 601-1 (1988) Medical Electrical Equipment, Part1, General Requirements for Safety.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K962308](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K962308)

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