Atlas FDA

IWB

48 FDA 510(k) clearances · Product code

90 daysmedian time to decision
220 days90th percentile
48clearances measured

FDA profile

Official device name
System, Radiation Therapy, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5750
Medical specialty
Radiology
Adverse events (MAUDE)
2007: 8 · 2008: 15 · 2009: 8 · 2010: 9 · 2011: 5 · 2014: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) (K250391)Elekta Solutions AB2025-07-02
Leksell GammaPlan (LGP) (K232854)Elekta Solutions AB2024-02-08
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) (K222047)Elekta Solutions AB2022-10-26
TaiChiC (K203250)Our United Corporation2021-03-12
Akesis Galaxy RTi (K203146)Akesis, Inc.2021-03-05
Akesis Galaxy RTx (K200050)Akesis, Inc.2020-02-04
Akesis Galaxy (K190844)Akesis, Inc.2019-09-04
GammaPod (K180571)Xcision Medical Systems, LLC2018-04-04
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (K173789)Elekta Instrument AB2018-03-30
Leksell GammaPlan (K173791)Elekta Instrument AB2018-02-09
GammaPod - Model A (K172706)Xcision Medical Systems, LLC2017-12-22
Leksell Gamma Knife Icon (K160440)Elekta Instrument AB2016-04-20
Leksell Gamma Knife Perfexion (K151159)Elekta Instrument AB2015-10-29
Leksell Gamma Knife Icon (K151561)Elekta Instrument AB2015-08-04
GammaBeam 500 (K150191)Best Theratronics Limited2015-04-17
GammaBeam 100 (K142219)Best Theratronics Limited2014-11-13
LEKSELL GAMMA KNIFE PERFEXION (K133565)Elekta Instrument AB2014-05-09
HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM (K131777)Hyper Technology, Inc.2014-02-28
LEKSELL GAMMA KNIFE PERFEXION (K120811)Elekta Instrument AB2012-05-24
ROTATING GAMMA SYSTEM INFINI (INFINI) (K102533)Masep Medical Science & Tech.Development (Shenzhen2011-03-22
EXTEND FRAME SYSTEM, MODEL 1009633 (K092083)Elekta Instrument AB2009-09-22
LEKSELL GAMMA KNIFE PERFEXION (K063512)Elekta Instrument AB2007-03-05
LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 (K061941)Elekta Instrument AB2006-08-21
LEKSELL GAMMAPLAN (K061540)Elekta Instrument AB2006-07-05
ROTATING GAMMA SYSTEM. GAMMA ART-6000 (K060314)American Radiosurgery, Inc.2006-04-06
THERATRON EQUINOX, MODELS 80 CM AND 100 CM (K053485)Mds Nordion, Inc.2006-03-09
GAMMAPLAN (K051022)Elekta Instrument AB2005-06-01
MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) (K041125)Masep Med Science & Tech. Development (Shenzhen) C2004-12-30
THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE (K001006)Mds Nordion2000-04-27
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 (K000478)Accuray, Inc.2000-04-19
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY (K984563)Accuray, Inc.1999-07-14
LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 (K984328)Elekta Instrument AB1999-05-21
THERATRON ELITE (K983917)Theratronics, Inc.1998-12-04
LEKSELL GAMMAPLAN (K973441)Patterson Consulting Group, Inc.1998-04-01
THERATRON 780E (K964606)Theratronics, Inc.1997-06-26
OUR ROTATING GAMMA SYSTEM (K970647)Our Scientific Intl., Inc.1997-05-20
THE COBALT SCALPEL (K960892)Nova Therapeutic System1996-06-03
LEKSELL GAMMA UNIT MODEL 23004,TYPE B. (K924849)Elekta Radiosurgery, Inc.1995-11-20
DPD-510 THERAPEUTIC RADIATION DOSIMETER (K925133)Scanditronix, Inc.1993-01-04
LEKSELL GAMMAPLAN (LGP) (K914808)Elekta Instruments, Inc.1992-01-23
ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES (K912250)Theta Systems, Inc.1991-11-05
THERATRON 1000 (K894165)Theratronics, Inc.1990-02-01
DISPOSABLE SHADOW TRAY INSERTS (K871215)Mick Radio-Nuclear Instruments, Inc.1987-04-06
THERATRON-PHOENIX (K863180)Aecl Medical1986-10-27
MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM (K860849)Marx Pland1986-04-08
THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY (K850543)Atomic Energy of Canada1985-05-10
STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE (K827583)Nucletronix, Inc.1982-09-29
SYSTEM, PLANNING, TREATMENT (K780948)Emi Therapy Systems, Inc.1978-06-22

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Every clearance here is in the API, with alerts when new ones post.