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K Number
K120520
Device Name
EXACTRAC ROBOTICS NOVALIS ROBOTICS
Manufacturer
BRAINLAB AG
Date Cleared
2012-06-29

(129 days)

Product Code
JAI
Regulation Number
892.5770
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 892.5770 Powered radiation therapy patient support assembly.

(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.