Device Name
DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEMManufacturer
Date Cleared
1996-09-27
(86 days)
Product Code
Regulation Number
892.5900Type
TraditionalPanel
RadiologyAge Range
N/A
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. 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.