FDA 510(k)

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)

Número K: K222047 · 2022-10-26

Data da decisão2022-10-26

Código do produtoIWB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) 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 2022-10-26 under 510(k) number K222047. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)?

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Elekta Solutions AB. The 510(k) number is K222047.

When did Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) receive FDA 510(k) clearance?

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) received FDA 510(k) clearance on 2022-10-26, under 510(k) number K222047.

Who is the listed applicant for Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)?

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 Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)?

The FDA product code for Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) is IWB.

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

K261932Leksell® Vantage Stereotactic System 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)

Ver todos os 15 dispositivos →

Dispositivos Relacionados (Código: IWB)

K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)Elekta Solutions AB K232854Leksell GammaPlan (LGP)Elekta Solutions AB K203250TaiChiCOur United Corporation K203146Akesis Galaxy RTiAkesis, Inc.K200050Akesis Galaxy RTxAkesis, Inc.K190844Akesis GalaxyAkesis, Inc.

Fonte oficial

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