XVI R5.0

Accelerator, Linear, Medical

Elekta Limited

The following data is part of a premarket notification filed by Elekta Limited with the FDA for Xvi R5.0.

Pre-market Notification Details

Device IDK131965
510k NumberK131965
Device Name:XVI R5.0
ClassificationAccelerator, Linear, Medical
Applicant Elekta Limited LINAC HOUSE, FLEMING WAY Crawley, West Sussex,  GB Rh10 9rr
ContactAndrew Hedges
CorrespondentAndrew Hedges
Elekta Limited LINAC HOUSE, FLEMING WAY Crawley, West Sussex,  GB Rh10 9rr
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-27
Decision Date2013-09-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060191071208 K131965 000
05060191071093 K131965 000
05060191071109 K131965 000
05060191071116 K131965 000
05060191071123 K131965 000
05060191071130 K131965 000
05060191071147 K131965 000
05060191071154 K131965 000
05060191071161 K131965 000
05060191071178 K131965 000
05060191071185 K131965 000
05060191071192 K131965 000
05060191071048 K131965 000

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