Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Leksell Vantage Stereotactic System

K-Number: K190887 · 2019-08-01

ApplicantElekta Instrument AB
Decision Date2019-08-01
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 2019-08-01 under approval number K190887. 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 2019-08-01. It is manufactured by Elekta Instrument AB. The 510(k) number is K190887.

When was Leksell Vantage Stereotactic System approved by the FDA?

Leksell Vantage Stereotactic System received FDA 510(k) clearance on 2019-08-01, under approval number K190887.

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.

Related Clinical Trials

NCT06861309 Placental Imaging Techniques RECRUITING NCT04905069 Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer ACTIVE_NOT_RECRUITING NCT04988750 Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients COMPLETED

Other Devices by Elekta Instrument AB

K160440Leksell Gamma Knife Icon K152558Leksell Stereotactic System, Injection/ Aspiration Needle Kit K171123Leksell Vantage Stereotactic System K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon K173791Leksell GammaPlan

Related Devices (Code: HAW)

K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

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.

↑