LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM

K960700 · GE Medical Systems · IYO · Aug 28, 1996 · Radiology

Device Facts

• Record ID: K960700
• Device Name: LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: GE Medical Systems
• Product Code: IYO · Radiology
• Decision Date: Aug 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The LOGIQ α200 diagnostic ultrasound system is intended for use in diagnostic ultrasound imaging using B, M, and B/M combination modes in the following areas: Fetal Abdominal Intraoperative Pediatric Small organs including breast, neck, chest, male and female reproductive organs, limbs, and extremities Adult Cephalic Neonatal cephalic Adult cardiac Pediatric cardiac Trans-vaginal Trans-rectal

Device Story

Mobile diagnostic ultrasound system; console-based; 40x60x125 cm; 70 kg. Inputs: ultrasound signals via linear, convex, micro-convex probes. Processing: B, M, B/M mode imaging. Outputs: real-time ultrasound images on monochrome monitor; optional integrated storage/hard-copy. Used in clinical settings by trained healthcare professionals. Facilitates diagnostic visualization of internal anatomy; supports clinical decision-making through standard ultrasound imaging.

Clinical Evidence

Bench testing only. Evaluated for acoustic output, biocompatibility, thermal, electrical, and mechanical safety. Conforms to applicable medical device safety standards. No clinical data presented.

Technological Characteristics

Mobile console; monochrome monitor; keyboard interface. Supports linear, convex, micro-convex probes. Imaging modes: B, M, B/M. Design conforms to GMP standards.

Indications for Use

Indicated for diagnostic ultrasound imaging in fetal, abdominal, intraoperative, pediatric, small organ (breast, neck, chest, reproductive, limbs), adult/neonatal cephalic, adult/pediatric cardiac, trans-vaginal, and trans-rectal 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

• GE Medical Systems RT2800 diagnostic ultrasound system (K873700)

Submission Summary (Full Text)

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K960700

AUG 28 1996

# 510(k) Summary of Safety and Effectiveness

GE LOGIQ α200 Premarket Notification - February 19, 1996

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

**Identification of Submitter:**
GE Medical Systems
PO Box 414
Milwaukee, WI 53201

**Contact:**
D. Duersteler, Safety/Regulatory Engineer
414-647-4385

**Date Prepared:**
February 19, 1996

**Product Identification:** GE LOGIQ α200 Diagnostic Ultrasound System

**Marketed Devices:** The GE LOGIQ α200 is of a comparable type and substantially equivalent to the GE Medical Systems RT2800 diagnostic ultrasound system, 510(k) Number K873700, currently in commercial distribution:

**Device Description:** The LOGIQ α200 diagnostic ultrasound system consists of a mobile console approximately 40 cm wide, 60 cm deep and 125 cm high, weighing approximately 70 kg. The user interface consists of a keyboard and monochrome video monitor. The system is designed for use in linear and convex scanning modes and supports linear, convex and micro convex probes. Optional image storage or hard-copy devices are integrated into the design.

**Indications for Use:** The LOGIQ α200 diagnostic ultrasound system is intended for use in diagnostic ultrasound imaging using B, M, and B/M combination modes in the following areas:

- Fetal
- Abdominal
- Intraoperative
- Pediatric
- Small organs including breast, neck, chest, male and female reproductive organs, limbs, and extremities
- Adult Cephalic
- Neonatal cephalic
- Adult cardiac
- Pediatric cardiac
- Trans-vaginal
- Trans-rectal

**Comparison with Predicate Device:** The GE LOGIQ α200 is comparable in key safety and effectiveness features, uses similar design, construction, and materials, and has the same intended uses and operating modes as the predicate device.

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Summary of Studies: The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.

Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with GMP standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE LOGIQ α200 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.