CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31

• K Number: K003689
• Device Name: CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
• Manufacturer: CANON U.S.A., INC.
• Date Cleared: 2002-01-02 ( 398 days)
• Product Code: IXK
• Regulation Number: 892.1630

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

§ 892.1630 Electrostatic x-ray imaging system.

(a)
Identification. An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

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