SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM

K962882 · Siemens Medical Solutions USA, Inc. · IYO · Apr 24, 1997 · Radiology

Device Facts

• Record ID: K962882
• Device Name: SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYO · Radiology
• Decision Date: Apr 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SONOLINE Versa Pro ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal Cephalic, Urology, Vascular, Peripheral Vascular, and Laparoscopic applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Device Story

SONOLINE Versa Pro is a mobile, software-controlled diagnostic ultrasound system. Input: ultrasonic pulses transmitted into patient via transducer; return echoes received and processed. Output: B-Mode, M-Mode, Color Flow, Pulsed (PW) Doppler, and Continuous (CW) Doppler images on CRT display. Includes 6.5 MHz laparoscopic probe for intra-abdominal exams via small incisions. Used in clinical settings by healthcare professionals. System provides anatomical measurements and analysis packages for clinical diagnosis. Benefits: enables non-invasive visualization of internal structures and disease states.

Clinical Evidence

Bench testing only. System complies with UL 2601, CSA 22.2 No. 601-1, AIUM/NEMA 1992 standards for thermal/mechanical indices, and EN60601 safety/EMC requirements.

Technological Characteristics

Mobile ultrasound system; software-controlled electronics; linear array transducer (6.5 MHz); CRT display. Complies with UL 2601, CSA 22.2 No. 601-1, and IEC 601-1-1/1-2. Displays real-time thermal and mechanical indices per AIUM/NEMA 1992.

Indications for Use

Indicated for diagnostic ultrasound imaging and measurement of anatomical structures in general radiology, abdominal, intraoperative, small parts, transcranial, OB/GYN, pelvic, neonatal cephalic, urology, vascular, peripheral vascular, and laparoscopic applications.

Regulatory Classification

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.

Predicate Devices

• Siemens SONOLINE Versa Diagnostic Ultrasound System (K945773)
• Tetrad Corp., Laparoscope Ultrasound Transducer (K924204)

Submission Summary (Full Text)

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Siemens Medical Systems, Inc.
Ultrasound Group
SONOLINE Versa Pro Ultrasound System
Addition of 6.5 MHz Laparoscopic Probe
K962882

# 510(K) SUMMARY

SONOLINE ® Versa Pro Diagnostic Ultrasound System, Addition of 6.5 MHz Laparoscopic Probe

APR 24 1997

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

1. Submitted By:
Siemens Medical Systems, Inc., Ultrasound Group
22010 SE 51st Street
Issaquah, WA 98027-7002

Contact Person:
Steve Hesler
Manager of Regulatory Affairs
[phone]

Date Prepared:
July 22, 1996

2. Proprietary Name:
SONOLINE Versa Pro Diagnostic Ultrasound System

Common/Usual Name:
Diagnostic Ultrasound System with Accessories

Classification Name:
Ultrasonic Pulsed Doppler Imaging System (Product Code 90 YIN, 21 CFR 892.1550)

3. Predicate Device:
Siemens SONOLINE Versa Diagnostic Ultrasound System (K945773), 8/7/95.
Tetrad Corp., Laparoscope Ultrasound Transducer (K924204), 6/7/93.

4. Device Description:
The SONOLINE Versa Pro is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Flow Modes, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.

The SONOLINE Versa Pro has been designed to meet the following product safety standards:

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K962882
Siemens Medical Systems, Inc.
Ultrasound Group
SONOLINE Versa Pro Ultrasound System
Addition of 6.5 MHz Laparoscopic Probe

- UL 2601, Safety Requirements for Medical Equipment
- CSA 22.2 No. 601-1, Safety Requirements for Medical Equipment
- Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment, AIUM/NEMA, 1992.
- 93/94/EEC Medical Devices Directive
- EN60601 = (IEC 601-1-1 + IEC 601-1-2), Safety and EMC, Requirements for Medical Equipment

## 5. Intended Uses:

The SONOLINE Versa Pro ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal Cephalic, Urology, Vascular, Peripheral Vascular, and Laparoscopic applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

## 6. Technological Comparison to Predicate Device:

The SONOLINE Versa Pro is identical to the SONOLINE Versa in that both incorporate software controlled electronics to transmit ultrasonic pulses, via a transducer, into a patient, then receive return (echo) pulses and to convert those pulses into a visual display, to be provided information for use in the diagnosis of various disease states as well as normal conditions such as pregnancy and physical development. The operating principles of both systems are identical.

The Siemens 6.5 MHz Laparoscopic Probe is technologically equivalent to the Tetrad Laparoscope in that both incorporate a linear array transducer of 6.0 MHz center frequency on the end of an articulating arm. Both are intended for intra-abdominal ultrasound examinations via small abdominal incisions.

End of 510(k) Summary

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