FDA 510(k)

Leksell® Vantage Stereotactic System

Número K: K261932 · 2026-08-05

Data da decisão2026-08-05

Código do produtoHAW

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Leksell® Vantage Stereotactic System is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Solutions AB. It received FDA 510(k) clearance on 2026-08-05 under 510(k) number K261932. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

O que é o Sistema Estereotáctico Leksell® Vantage?

Leksell® Vantage Stereotactic System is a medical device that received FDA 510(k) clearance on 2026-08-05. The listed applicant is Elekta Solutions AB. The 510(k) number is K261932.

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

Leksell® Vantage Stereotactic System received FDA 510(k) clearance on 2026-08-05, under 510(k) number K261932.

Who is the listed applicant for Leksell® Vantage Stereotactic System?

The FDA 510(k) record lists Elekta Solutions 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.

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Outros registros que listam Elekta Solutions AB como candidato(a)

K252002Monaco RTP System (6.3)K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)K251363ProKnow DS K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)K232854Leksell GammaPlan (LGP)K223229MOSAIQ® OIS (Oncology Information System)

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Dispositivos Relacionados (Código: HAW)

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Fonte oficial

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