SIEMENS Q64XXX

K950157 · Siemens Medical Solutions USA, Inc. · IYO · Apr 5, 1996 · Radiology

Device Facts

• Record ID: K950157
• Device Name: SIEMENS Q64XXX
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYO · Radiology
• Decision Date: Apr 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Q64XXX ultrasound imaging system is intended for the following applications: General Radiology; Abdomen; Intraoperative; Small Parts; Transcranial; OB/GYN; Neonatal Cephalic; Urology; Vascular; Peripheral Vascular; Vascular Doppler. 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

Mobile, software-controlled diagnostic ultrasound system; acquires ultrasound data via transducers; displays in B-Mode, M-Mode, Color Flow, PW Doppler, and CW Doppler on CRT. Used in clinical settings by healthcare professionals for anatomical imaging and measurement. Incorporates real-time on-screen display of thermal (TI) and mechanical (MI) indices. Output used by clinicians to assess anatomical structures and support clinical diagnosis.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and compliance with safety standards.

Technological Characteristics

Mobile diagnostic ultrasound system; software-controlled electronics; CRT display. Complies with UL 544, CSA 22.2 No. 601-1, IEC 601-1-1/1-2, and AIUM/NEMA 1992 standards for thermal/mechanical indices. Supports multiple imaging modes (B, M, Color Flow, Doppler).

Indications for Use

Indicated for general radiology, abdominal, intraoperative, small parts, transcranial, OB/GYN, neonatal cephalic, urological, and vascular diagnostic ultrasound imaging and measurement.

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 Quantum™ 2000 Ultrasound System (K904019/A)
• Assorted Diagnostic Ultrasound Transducers (K904019/A)
• Siemens SONOLINE™ SI1200 Ultrasound System (K904564/A)

Submission Summary (Full Text)

{0}

Siemens Medical Systems, Inc.
Ultrasound Group
Q64XXX Ultrasound System
510(k) Submission

# SECTION 7

5 950157

# Q64XXX 510(K) SUMMARY

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 S.E. 51st Street
Issaquah, WA 98027-7002

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

Date Prepared:
January 16, 1995

2. Proprietary Name:
Q64XXX Diagnostic Ultrasound System

Common/ Usual Name:
Diagnostic Ultrasound System with Accessories

Classification Name:
Ultrasonic Pulsed Doppler Imaging System (Product Code 90 IYN, 21 CFR 92.1550)

Diagnostic Ultrasonic Transducer:
(Product Code 90 ITX, 21 CFR 892.1570)

3. Predicate Device:
- Siemens Quantum™ 2000 Ultrasound System (K904019/A)
- Assorted Diagnostic Ultrasound Transducers (K904019/A)
- Siemens SONOLINE™ SI1200 Ultrasound System (K904564/A)

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Siemens Medical Systems, Inc.
Ultrasound Group
Q64XXX Ultrasound System
510(k) Submission

# 4. Device Description:

The Q64XXX 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 Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.

The Q64XXX, has been designed to meet the following product safety standards:

- UL 544, 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/NÉMA, 1992.
- CE Mark and CB Certificate Certifying Compliance To:
- EN29001, Quality Systems
- EN46001, Quality Systems for Medical Device Manufacturers
- 89/336/EEC EMC Directive
- EN 50081-2, Electromagnetic Emissions Requirements
- EN 55011B, Group 1 = CISPR 11B, Group 1, RF Radiated/Conducted Emission Limits
- EN 50082-2, Electromagnetic Immunity Requirements
- IEC 801-2, Electrostatic Discharge Immunity
- IEC 801-3, Radiated RF Field Immunity
- IEC 801-4, Power Line Fast Transient/Burst Immunity
- 93/94/EEC Medical Devices Directive
- EN60601 = (IEC 601-1-1 + IEC 601-1-2), Safety and EMC Requirements for Medical Equipment
- CISPR11B, Group 1 = EN55011B, Group 1
- CISPR14, subclause 4.2 (clicks) = EN 55014, Intermittent
- Radiated RF Emissions Limits
- IEC 801-5 (draft), Power Line Surge Immunity

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Siemens Medical Systems, Inc.
Ultrasound Group
Q64XXX Ultrasound System
510(k) Submission

## 5. Intended Uses:

The Q64XXX ultrasound imaging system is intended for the following applications: General Radiology; Abdomen; Intraoperative; Small Parts; Transcranial; OB/GYN; Neonatal Cephalic; Urology; Vascular; Peripheral Vascular; Vascular Doppler.

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 Q64XXX is similar to the Quantum™ 2000 and the SONOLINE® SI1200 in that all three incorporate software controlled electronics to transmit ultrasonic pulses, via an applicator/transducer, into a patient, then receive return (echo) pulses and to convert those pulses into a visual display, to be used for diagnosis of various disease states. The operating principles of all three systems are the same. However, the Q64XXX incorporates an on-screen display of Mechanical (MI) and Thermal (TI) Indices, in compliance with the *Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment*, AIUM/NEMA, 1992.

END OF SECTION 7

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