SHADOWFORM

• K Number: K964972
• Device Name: SHADOWFORM
• Manufacturer: I.Z.I. MEDICAL PRODUCTS CORP.
• Date Cleared: 1997-05-05 ( 144 days)
• Product Code: KPQ
• Regulation Number: 892.5840

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

§ 892.5840 Radiation therapy simulation system.

(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.

Summary

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