System, Radiation Therapy, Radionuclide

FDA product code IWB · 42 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.5750
Review panel: RA
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-06-22 – 2025-07-02

IWB 2025-07-02

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)

Applicant Elekta Solutions AB

K number K250391

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IWB 2024-02-08

Leksell GammaPlan (LGP)

Applicant Elekta Solutions AB

K number K232854

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IWB 2022-10-26

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

Applicant Elekta Solutions AB

K number K222047

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IWB 2021-03-12

TaiChiC

Applicant Our United Corporation

K number K203250

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IWB 2021-03-05

Akesis Galaxy RTi

Applicant Akesis, Inc.

K number K203146

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IWB 2020-02-04

Akesis Galaxy RTx

Applicant Akesis, Inc.

K number K200050

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IWB 2019-09-04

Akesis Galaxy

Applicant Akesis, Inc.

K number K190844

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IWB 2018-04-04

GammaPod

Applicant Xcision Medical Systems, LLC

K number K180571

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IWB 2018-03-30

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon

Applicant Elekta Instrument AB

K number K173789

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IWB 2018-02-09

Leksell GammaPlan

Applicant Elekta Instrument AB

K number K173791

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IWB 2017-12-22

GammaPod - Model A

Applicant Xcision Medical Systems, LLC

K number K172706

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IWB 2016-04-20

Leksell Gamma Knife Icon

Applicant Elekta Instrument AB

K number K160440

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IWB 2012-05-24

LEKSELL GAMMA KNIFE PERFEXION

Applicant Elekta Instrument AB

K number K120811

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IWB 2011-03-22

ROTATING GAMMA SYSTEM INFINI (INFINI)

Applicant Masep Medical Science & Tech.Development (Shenzhen

K number K102533

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IWB 2009-09-22

EXTEND FRAME SYSTEM, MODEL 1009633

Applicant Elekta Instrument AB

K number K092083

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IWB 2007-03-05

LEKSELL GAMMA KNIFE PERFEXION

Applicant Elekta Instrument AB

K number K063512

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IWB 2006-08-21

LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000

Applicant Elekta Instrument AB

K number K061941

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IWB 2006-07-05

LEKSELL GAMMAPLAN

Applicant Elekta Instrument AB

K number K061540

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IWB 2006-04-06

ROTATING GAMMA SYSTEM. GAMMA ART-6000

Applicant American Radiosurgery, Inc.

K number K060314

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IWB 2006-03-09

THERATRON EQUINOX, MODELS 80 CM AND 100 CM

Applicant Mds Nordion, Inc.

K number K053485

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IWB 2005-06-01

GAMMAPLAN

Applicant Elekta Instrument AB

K number K051022

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IWB 2004-12-30

MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)

Applicant Masep Med Science & Tech. Development (Shenzhen) C

K number K041125

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IWB 2000-04-27

THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE

Applicant Mds Nordion

K number K001006

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IWB 2000-04-19

THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1

Applicant Accuray, Inc.

K number K000478

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IWB 1999-07-14

THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY

Applicant Accuray, Inc.

K number K984563

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IWB 1999-05-21

LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001

Applicant Elekta Instrument AB

K number K984328

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IWB 1998-12-04

THERATRON ELITE

Applicant Theratronics, Inc.

K number K983917

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IWB 1998-04-01

LEKSELL GAMMAPLAN

Applicant Patterson Consulting Group, Inc.

K number K973441

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IWB 1997-06-26

THERATRON 780E

Applicant Theratronics, Inc.

K number K964606

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IWB 1997-05-20

OUR ROTATING GAMMA SYSTEM

Applicant Our Scientific Intl., Inc.

K number K970647

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IWB 1996-06-03

THE COBALT SCALPEL

Applicant Nova Therapeutic System

K number K960892

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IWB 1995-11-20

LEKSELL GAMMA UNIT MODEL 23004,TYPE B.

Applicant Elekta Radiosurgery, Inc.

K number K924849

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IWB 1993-01-04

DPD-510 THERAPEUTIC RADIATION DOSIMETER

Applicant Scanditronix, Inc.

K number K925133

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IWB 1992-01-23

LEKSELL GAMMAPLAN (LGP)

Applicant Elekta Instruments, Inc.

K number K914808

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IWB 1991-11-05

ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES

Applicant Theta Systems, Inc.

K number K912250

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IWB 1990-02-01

THERATRON 1000

Applicant Theratronics, Inc.

K number K894165

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IWB 1987-04-06

DISPOSABLE SHADOW TRAY INSERTS

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K871215

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IWB 1986-10-27

THERATRON-PHOENIX

Applicant Aecl Medical

K number K863180

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IWB 1986-04-08

MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM

Applicant Marx Pland

K number K860849

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IWB 1985-05-10

THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY

Applicant Atomic Energy of Canada

K number K850543

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IWB 1982-09-29

STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE

Applicant Nucletronix, Inc.

K number K827583

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IWB 1978-06-22

SYSTEM, PLANNING, TREATMENT

Applicant Emi Therapy Systems, Inc.

K number K780948

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