IWB

Product Code: IWB


Products Classified as IWB

5280System, Radiation Therapy, RadionuclideRadionuclide Radiation Therapy System.

Total Product Life Cycle (TPLC) Devices

5280System, Radiation Therapy, RadionuclideRadionuclide Radiation Therapy System.

FDA Consensus Standards

System, Radiation Therapy, Radionuclide [31229]21 CFR §892.5750 🔎
System, Radiation Therapy, Radionuclide [32082]21 CFR §892.5750 🔎
System, Radiation Therapy, Radionuclide [28999]21 CFR §892.5750 🔎
System, Radiation Therapy, Radionuclide [34832]21 CFR §892.5750 🔎
System, Radiation Therapy, Radionuclide [37591]21 CFR §892.5750 🔎
System, Radiation Therapy, Radionuclide [29957]21 CFR §892.5750 🔎
System, Radiation Therapy, Radionuclide [32087]21 CFR §892.5750 🔎

Pre-market Notifications for IWB

K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New Model Variant)Elekta Solutions AB
K203250TaiChiCOur United Corporation
K203146Akesis Galaxy RTiAkesis Inc
K200050Akesis Galaxy RTxAkesis Inc
K190844Akesis GalaxyAkesis Inc
K180571GammaPodXcision Medical Systems, LLC
K173791Leksell GammaPlanElekta Instrument AB
K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB
K172706GammaPod - Model AXcision Medical Systems, LLC
K160440Leksell Gamma Knife IconElekta Instrument AB
K151561Leksell Gamma Knife IconELEKTA INSTRUMENT AB
K151159Leksell Gamma Knife PerfexionELEKTA INSTRUMENT AB
K150191GammaBeam 500Best Theratronics Limited
K142219GammaBeam 100Best Theratronics Limited
K133565LEKSELL GAMMA KNIFE PERFEXIONELEKTA INSTRUMENT AB

Global Unique Device Identification Database

00754014600076System, Radiation Therapy, Radionuclide
00754014600069System, Radiation Therapy, Radionuclide
00754014600038System, Radiation Therapy, Radionuclide
00850002615074System, Radiation Therapy, Radionuclide
00850002615067System, Radiation Therapy, Radionuclide
00850002615050System, Radiation Therapy, Radionuclide
00850002615043System, Radiation Therapy, Radionuclide
00850002615036System, Radiation Therapy, Radionuclide
00850002615029System, Radiation Therapy, Radionuclide
00850002615012System, Radiation Therapy, Radionuclide
00850002615005System, Radiation Therapy, Radionuclide
07540180000153System, radiation therapy, radionuclide
07540180000139System, radiation therapy, radionuclide
07540180000122System, radiation therapy, radionuclide
07540180000115System, radiation therapy, radionuclide

Maude Adverse Events

LEKSELL GAMMA KNIFE PERFEXIONELEKTA INSTRUMENT AB2020-03-20
GAMMA KNIFE RADIOSURGERYELEKTA INSTRUMENT AB2019-07-29
SYSTEM RADIATION THERAPY2017-11-27
LEKSELL GAMMA KNIFE ICONELEKTA INSTRUMENT AB2017-09-08
LEKSELL GAMMA KNIFE ICONELEKTA INSTRUMENT AB2017-03-30
LEKSELL GAMMA KNIFE ICONELEKTA INSTRUMENT AB2017-03-08
LEKSELL GAMMA KNIFE ICONELEKTA INSTRUMENT AB2016-11-09
LEKSELL GAMMA KNIFE PERFEXIONELEKTA INSTRUMENT AB2016-10-13
LEKSELL GAMMA KNIFE PERFEXIONELEKTA INSTRUMENT AB2016-10-12
LEKSELL GAMMA KNIFE ICONELEKTA INSTRUMENT AB2016-04-01
ELEKTAELEKTA2016-03-18
LEKSELL GAMMA KNIFE PERFEXIONELEKTA INSTRUMENT AB2016-03-15
LEKSELL GAMMA KNIFE ICONELEKTA INSTRUMENT AB2016-01-05
LEKSELL GAMMA KNIFE ICONELEKTA INSTRUMENT AB2015-11-04
LEKSELL GAMMA KNIFE PERFEXIONELEKTA INSTRUMENT AB2015-10-16
GAMMABEAM 100BEST THERATRONICS LTD.2015-07-21
LEKSELL GAMMA KNIFE PERFEXIONELEKTA INSTRUMENT AB2015-03-20
LEKSELL GAMMA KNIFEELEKTA INSTRUMENT AB2015-02-17
LEKSELL GAMMA KNIFE PERFEXION WITH EXTEND FRAME SYSTEMELEKTA INSTRUMENT AB2014-11-27
LEKSELL GAMMA KNIFEELEKTA INSTRUMENT AB2014-09-09
LEKSELL GAMMA KNIFE PERFEXIONELEKTA INSTRUMENT AB2014-06-02
LEKSELL GAMMA KNIFE PERFEXIONELEKTA INSTRUMENT AB2014-05-16
THERATRONBEST THERATRONICS LTD.2014-05-13
LEKSELL GAMMA KNIFE 4CELEKTA INSTRUMENT AB2014-03-11
ELEKTA INC2014-02-03
THERATRONBEST THERATRONICS LTD2014-01-15
LEKSELL GAMMA KNIFE PERFEXIONELEKTA INSTRUMENT AB2013-12-10
LEKSELL GAMMA KNIFE 4CELEKTA INSTRUMENT AB2013-06-17
THERATRONBEST THERATRONICS LTD2012-12-24
LEKSELL GAMMA KNIFEELEKTA INSTRUMENT AB2012-05-30
LEKSELL GAMMA KNIFEELEKTA INSTRUMENT, AB.2012-04-26
LIKSELL GAMMA KNIFEELEKTA INSTRUMENT AB2011-07-20
LEKSELL GAMMAPLANELEKTA INSTRUMENT AB2011-06-14
LEKSELL GAMMA KNIFEELEKTA INSTRUMENT AB2011-04-05
LEKSELL GAMMA KNIFEELEKTA INSTRUMENT AB2011-04-05
STAR PROTON BEAM2011-04-01
GAMMA KNIFE2010-12-04
LEKSELL STEROTACTIC SYSTEMELEKTA, LTD.2010-11-02
LEKSELL GAMMA KNIFE PERFEXION WITH EXTEND FRAME SYSTEMELEKTA INSTRUMENT AB2010-10-12
LEKSELL GAMMA KNIFE PERFEXION WITH EXTEND FRAME SYSTEMELEKTA INSTRUMENT AB2010-09-27
LEKSELL GAMMA KNIFEELEKTA INSTRUMENT AB2010-09-02
LEKSELL GAMMA KNIFEELEKTA INSTRUMENT AB2010-06-15
LEKSELL GAMMA KNIFEELEKTA INSTRUMENT AB2010-03-01
ELEKTA GAMMAKNIFE, ABELEKTA, AB2010-01-26
LEKSELL GAMMA KNIFEELEKTA INSTRUMENT AB2010-01-21
LEKSELL GAMMA KNIFE PERFEXIONELEKTA INSTRUMENT AB2009-09-01
LESKELL GAMMAKNIFE MODEL C/B-2ELEKTA, AB2009-08-19
LEKSELL GAMMA KNIFE PERFEXIONELEKTA INSTRUMENT AB2009-07-20
LEKSELL GAMMA KNIFEELEKTA INSTRUMENT AB2009-06-18
ELEKTAELEKTA AB2009-06-04
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