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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05056190500689 K212583 000
05056190500672 K212583 000
05056190500597 K212583 000
05056190500580 K212583 000
05056190500863 K212583 000
05056190500214 K212583 000
05056190500986 K212583 000
05056190500979 K212583 000
05056190500962 K212583 000

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