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510(k) K232854

Device
Leksell GammaPlan (LGP)
Applicant
Elekta Solutions AB
510(k) number
K232854
Product code
IWB
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-08
Date received
2023-09-15
Regulation
892.5750
Classification name
System, Radiation Therapy, Radionuclide
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Simon Sjohage
Address
Kungstensgatan 18 Box 7593 Stockholm SE SE-10393 SE-10393

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IWB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)Elekta Solutions AB2025-07-02
K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)Elekta Solutions AB2022-10-26
K203250TaiChiCOur United Corporation2021-03-12
K203146Akesis Galaxy RTiAkesis, Inc.2021-03-05
K200050Akesis Galaxy RTxAkesis, Inc.2020-02-04
K190844Akesis GalaxyAkesis, Inc.2019-09-04
K180571GammaPodXcision Medical Systems, LLC2018-04-04
K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB2018-03-30
K173791Leksell GammaPlanElekta Instrument AB2018-02-09
K172706GammaPod - Model AXcision Medical Systems, LLC2017-12-22
K160440Leksell Gamma Knife IconElekta Instrument AB2016-04-20
K151159Leksell Gamma Knife PerfexionElekta Instrument AB2015-10-29
K151561Leksell Gamma Knife IconElekta Instrument AB2015-08-04
K150191GammaBeam 500Best Theratronics Limited2015-04-17
K142219GammaBeam 100Best Theratronics Limited2014-11-13