Leksell Vantage Stereotactic System

Neurological Stereotaxic Instrument

Elekta Instrument AB

The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Vantage Stereotactic System.

Pre-market Notification Details

Device IDK190887
510k NumberK190887
Device Name:Leksell Vantage Stereotactic System
ClassificationNeurological Stereotaxic Instrument
Applicant Elekta Instrument AB Kungstensgatan 18 Stockholm,  SE 10393
ContactHelena Skar
CorrespondentAlf Laurell
Elekta Instrument AB Kungstensgatan 18 Stockholm,  SE 10393
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-04
Decision Date2019-08-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07340048311625 K190887 000
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07340201501337 K190887 000
07340201501887 K190887 000
07340201501658 K190887 000
07340201501719 K190887 000
07340048311601 K190887 000
07340048311472 K190887 000
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07340201501764 K190887 000
07340201502198 K190887 000
07340201501825 K190887 000
07340201501757 K190887 000
07340201501511 K190887 000

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