AlignRT Plus

Accelerator, Linear, Medical

Vision RT Ltd

The following data is part of a premarket notification filed by Vision Rt Ltd with the FDA for Alignrt Plus.

Pre-market Notification Details

Device IDK212583
510k NumberK212583
Device Name:AlignRT Plus
ClassificationAccelerator, Linear, Medical
Applicant Vision RT Ltd Dove House, Arcadia Avenue London,  GB N3 2ju
ContactJade Dunphy
CorrespondentJade Dunphy
Vision RT Ltd Dove House, Arcadia Avenue London,  GB N3 2ju
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-16
Decision Date2021-11-10

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