APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K103645
• Device Name: APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
• Date Cleared: 2011-01-12 ( 30 days)
• Product Code: ITX DQK IYN IYO
• Regulation Number: 892.1570

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

Summary

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