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

FDA 510(k) K222047 · Elekta Solutions AB

Substantially Equivalent

510(k) numberK222047

Submission

Device name
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
Applicant
Elekta Solutions AB
Stockholm, SE
Received
July 12, 2022
Decision date
October 26, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IWB – System, Radiation Therapy, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5750
Specialty
Radiology

Other 510(k)s with product code IWB

510(k)DeviceApplicantDecision
K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…IWB · Traditional Elekta Solutions AB07/02/2025SE
K232854Leksell GammaPlan (LGP)IWB · Traditional Elekta Solutions AB02/08/2024SE
K203250TaiChiCIWB · Traditional Our United Corporation03/12/2021SE
K203146Akesis Galaxy RTiIWB · Traditional Akesis, Inc.03/05/2021SE
K200050Akesis Galaxy RTxIWB · Special Akesis, Inc.02/04/2020SE
K190844Akesis GalaxyIWB · Traditional Akesis, Inc.09/04/2019SE
K180571GammaPodIWB · Special Xcision Medical Systems, LLC04/04/2018SE
K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconIWB · Traditional Elekta Instrument AB03/30/2018SE
K173791Leksell GammaPlanIWB · Traditional Elekta Instrument AB02/09/2018SE
K172706GammaPod - Model AIWB · Traditional Xcision Medical Systems, LLC12/22/2017SE

More from Xcision Medical Systems, LLC

510(k)DeviceDecision
K261932Leksell® Vantage Stereotactic SystemHAW · Traditional 08/05/2026SE
K252002Monaco RTP System (6.3)MUJ · Traditional 02/19/2026SE
K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…IYE · Traditional 01/15/2026SE
K251363ProKnow DSLLZ · Traditional 10/08/2025SE
K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…IWB · Traditional 07/02/2025SE
K232854Leksell GammaPlan (LGP)IWB · Traditional 02/08/2024SE
K223233Monaco RTP SystemMUJ · Traditional 02/23/2023SE
K223229MOSAIQ® OIS (Oncology Information System)IYE · Traditional 02/23/2023SE
K223209Elekta UnityIYE · Traditional 02/23/2023SE
K213787Monaco RTP SystemMUJ · Traditional 05/17/2022SE

Questions and answers

When was Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) cleared by the FDA?

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) (K222047) received a 510(k) decision of Substantially Equivalent on October 26, 2022, 106 days after the submission was received.

What is the product code of K222047?

The FDA product code is IWB – System, Radiation Therapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5750.