IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM

• K Number: K010166
• Device Name: IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
• Manufacturer: IMAGYN MEDICAL TECHNOLOGIES, INC.
• Date Cleared: 2001-12-03 ( 319 days)
• Product Code: IWJ
• Regulation Number: 892.5650

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

§ 892.5650 Manual radionuclide applicator system.

(a)
Identification. A manual radionuclide applicator system is a manually operated device intended to apply 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 I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

Summary

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