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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 the device name listed in this FDA 510(k) record. The listed applicant is Elekta Instrument AB. It received FDA 510(k) clearance on 2019-08-01 under 510(k) 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. The listed applicant is Elekta Instrument AB. The 510(k) number is K190887.

When did Leksell Vantage Stereotactic System receive FDA 510(k) clearance?

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

Who is the listed applicant for Leksell Vantage Stereotactic System?

The FDA 510(k) record lists Elekta Instrument AB as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Elekta Instrument AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconK173791Leksell GammaPlanK171123Leksell Vantage Stereotactic SystemK160440Leksell Gamma Knife IconK152558Leksell Stereotactic System, Injection/ Aspiration Needle Kit

Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

Official Source

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

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