ClearanceBrief
Panels › Radiology › Product code IWB · Class 2

System, Radiation Therapy, Radionuclide

Regulation 892.5750

0510(k)s in 12 months (48 all time)
1recalls in 12 months (29 all time)
29recalls that name a 510(k)
Get daily alerts for IWBSample briefCSV

Top companies in IWB

DateFirm and productCodeLinked 510(k)
Mar 19, 2026Elekta, Inc.
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife Perfexion Leksell Gamma Knife Icon" Leksell Gamma Knife Elekta Esprit Leksell Gamma Knife (available models Elekta Esprit,
Open, Classified
IWBK250391
Jan 18, 2024Xcision Medical Systems, LLC
GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a parti
Open, Classified
IWBK172706
K180571
Jul 3, 2019Xcision Medical Systems, LLC
GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose
Terminated
IWBK180571
Jun 27, 2018Elekta Instrument AB
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Open, Classified
IWBK173791
May 31, 2017Elekta, Inc.
Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g., metasta
Terminated
IWBK160440
Apr 19, 2016Elekta, Inc.
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to
Terminated
IWBK151159
K151561
Jun 5, 2015Elekta, Inc.
Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
Terminated
IWBK103093
Oct 30, 2014Elekta, Inc.
Laksell Gamma Knife Perfexion
Terminated
IWBK120811
Nov 30, 2011Elekta, Inc.
Elekta Leksell Gamma Knife C 1.2, 4 and 4C Product Usage: Leksell Gamma Knife is a teletherapy device intended for stereotactic irradiation of head structures.
Terminated
IWBK984328
Nov 30, 2011Elekta, Inc.
Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.
Terminated
IWBK973441
Feb 14, 2011Elekta, Inc.
Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy.
Terminated
IWBK973441
Oct 28, 2010Elekta, Inc.
Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.
Terminated
IWBK092083
May 14, 2010Elekta, Inc.
Leksell GammaPlan 8.0 image fusion Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. the Leksell GammaPlan is intended to be used for planning t
Terminated
IWBK973441
Apr 29, 2010Elekta, Inc.
Leksell Gamma Knife C
Terminated
IWBK984328
Apr 27, 2010Elekta, Inc.
Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of
Terminated
IWBK973441
Apr 22, 2010Elekta, Inc.
Leksell Gamma Knife C
Terminated
IWBK984328
Apr 13, 2010Elekta, Inc.
Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures
Terminated
IWBK984328
Apr 5, 2010Elekta, Inc.
Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very sm
Terminated
IWBK063512
Apr 5, 2010Elekta, Inc.
Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in the stereotactic irradiation of intracranial structures.
Terminated
IWBK063512
Apr 5, 2010Elekta, Inc.
Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structu
Terminated
IWBK063512
Mar 17, 2010Elekta, Inc.
Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centim
Terminated
IWBK063512
Jun 27, 2006MDS Canada Inc. DBA MDS Nordion
Theratron Elite 100 Cobalt Radiotherapy
Terminated
IWBK983917
Jun 27, 2006MDS Canada Inc. DBA MDS Nordion
Theratron Elite 80 Cobalt Radiotherapy
Terminated
IWBK983917
Jun 27, 2006MDS Canada Inc. DBA MDS Nordion
Theratron Phoenix Cobalt Radiotherapy
Terminated
IWBK863180
Jun 27, 2006MDS Canada Inc. DBA MDS Nordion
Theratron 1000E Cobalt Radiotherapy
Terminated
IWBK964607
Jun 27, 2006MDS Canada Inc. DBA MDS Nordion
Theratron 1000 Cobalt Radiotherapy
Terminated
IWBK001006
Jun 27, 2006MDS Canada Inc. DBA MDS Nordion
Theratron 780E Cobalt Radiotherapy
Terminated
IWBK964606
Jun 27, 2006MDS Canada Inc. DBA MDS Nordion
Theratron 780C Cobalt Radiotherapy
Terminated
IWBK001006
Jan 18, 2006Varian Medical Systems Inc
Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and including v7.3.10 SP2 (used with BrainLab M3 MultiLeaf Collimator (MLC); Eclipse (used with BrainLab M3 MLC); Acui
Terminated
IWBK010975
K023052 +1

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.