RT55 DIAGNOSTIC ULTRASOUND SYSTEM

K953752 · General Electric Co. · IYO · Mar 15, 1996 · Radiology

Device Facts

• Record ID: K953752
• Device Name: RT55 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: General Electric Co.
• Product Code: IYO · Radiology
• Decision Date: Mar 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The RT55 portable ultrasound diagnostic system is intended for use in obstetrics, gynecology and general radiology examinations by a qualified physician to aid in the diagnosis and evaluation of soft tissues by generating two dimensional images, time-motion images and biometric data. The specific intended uses of this system include: abdominal, small parts, pediatric and fetal imaging.

Device Story

Portable ultrasound system (<10 kg); integrated monitor/keyboard. Supports linear, convex, and micro-convex probes. Used by physicians in clinical settings for abdominal, small parts, pediatric, and fetal imaging. Generates 2D images, time-motion images, and biometric data to aid soft tissue diagnosis. Physician interprets images/data to inform clinical decision-making.

Clinical Evidence

Bench testing only. Evaluated for acoustic output, biocompatibility, and thermal, electrical, and mechanical safety. Conforms to applicable medical device safety standards.

Technological Characteristics

Portable ultrasound system; <10 kg; dimensions ~28x41x29 cm. Supports linear, convex, and micro-convex probes. Operating modes: 2D, time-motion. Design conforms to GMP standards.

Indications for Use

Indicated for use in obstetrics, gynecology, and general radiology (abdominal, small parts, pediatric, fetal) to aid soft tissue diagnosis and evaluation via 2D, time-motion, and biometric data generation. For use by qualified physicians.

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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GE RT55 510k Premarket Notification
August 8, 1995
K953752
K953752

# Attachment A

## 510(k) Summary of Safety and Effectiveness

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:**
Allen Schuh, Manager, Regulatory Programs
414-548-4839

**Date Prepared:**
July 20, 1995

**Product Identification:** GE RT55 Diagnostic Ultrasound System

**Marketed Devices:** The GE RT55 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 RT55 is a portable ultrasound system weighing less than 10 kg., approximately 28 cm wide, 41 cm deep and 29 cm high with integrated monitor and keyboard. The system is designed for use in linear and convex scanning modes and supports linear, convex and micro convex probes.

**Indications for Use:** The RT55 portable ultrasound diagnostic system is intended for use in obstetrics, gynecology and general radiology examinations by a qualified physician to aid in the diagnosis and evaluation of soft tissues by generating two dimensional images, time-motion images and biometric data. The specific intended uses of this system include: abdominal, small parts, pediatric and fetal imaging.

**Comparison with Predicate Device:** The GE RT55 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.

**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 RT55 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.