MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM

• K Number: K000081
• Device Name: MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM
• Manufacturer: ISOTOPES AND METALS LTD.
• Date Cleared: 2000-12-19 ( 343 days)
• Product Code: JAQ
• Regulation Number: 892.5700

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

§ 892.5700 Remote controlled radionuclide applicator system.

(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.

Summary

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