EUB-8000

• K Number: K954220
• Device Name: EUB-8000
• Manufacturer: HITACHI MEDICAL CORP. OF AMERICA
• Date Cleared: 1997-05-07 ( 604 days)
• Product Code: IYN
• Regulation Number: 892.1550
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

Not Found

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, Transvaginal, Transvaginal, and Neonatal Cephalic. The EUB-8000 utilizes digital front-end electronics for detection of echo signals.

AI/ML Overview

The provided text is a summary of safety and effectiveness for the Hitachi EUB-8000 Ultrasound Electronic Scanner. It describes the device, its intended uses, and its compliance with safety standards regarding acoustic output and general electrical safety.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods. Therefore, I cannot generate the requested table or answer the specific questions about the study that proves the device meets acceptance criteria.

The document focuses on:

• Device Description: What the device is and its capabilities (B, M, Pulsed Doppler, Color Flow, CW Doppler modes).
• Intended Use: The clinical applications for which the probes are designed (Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral Vascular, Biopsy, Transvaginal, Transvaginal, and Neonatal Cephalic).
• Safety Compliance: Adherence to NEMA UD-3 for acoustic output and IEC 601-1 for general electrical safety.

To answer your questions, additional documentation detailing performance studies and clinical evaluation would be required.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.