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FDA 510(k)

Leksell Vantage Stereotactic System

K-Number: K171123 · 2017-09-15

ApplicantElekta Instrument AB
Decision Date2017-09-15
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Leksell Vantage Stereotactic System is a medical device manufactured by Elekta Instrument AB. It received FDA 510(k) clearance on 2017-09-15 under approval number K171123. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Leksell Vantage Stereotactic System?

Leksell Vantage Stereotactic System is a medical device that received FDA 510(k) clearance on 2017-09-15. It is manufactured by Elekta Instrument AB. The 510(k) number is K171123.

When was Leksell Vantage Stereotactic System approved by the FDA?

Leksell Vantage Stereotactic System received FDA 510(k) clearance on 2017-09-15, under approval number K171123.

What company makes Leksell Vantage Stereotactic System?

Leksell Vantage Stereotactic System is manufactured by Elekta Instrument AB.

What is the FDA product code for Leksell Vantage Stereotactic System?

The FDA product code for Leksell Vantage Stereotactic System is HAW.

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Other Devices by Elekta Instrument AB

K160440Leksell Gamma Knife Icon K152558Leksell Stereotactic System, Injection/ Aspiration Needle Kit K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon K173791Leksell GammaPlan K190887Leksell Vantage Stereotactic System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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