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)
Top companies in IWB
| Company | 510(k)s | Recalls |
|---|---|---|
| Elekta, Inc. | 0 | 18 |
| Elekta Instrument AB | 13 | 1 |
| MDS Canada Inc. DBA MDS Nordion | 0 | 7 |
| Xcision Medical Systems, LLC | 2 | 2 |
| Akesis, Inc. | 3 | 0 |
| Elekta Solutions AB | 3 | 0 |
| Theratronics, Inc. | 3 | 0 |
| Accuray, Inc. | 2 | 0 |
| Best Theratronics Limited | 2 | 0 |
| Mds Nordion | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2026 | Elekta, 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 |
IWB | K250391 |
| Jan 18, 2024 | Xcision 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 |
IWB | K172706 K180571 |
| Jul 3, 2019 | Xcision 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 |
IWB | K180571 |
| Jun 27, 2018 | Elekta Instrument AB Leksell GammaPlan 11.1
Product Usage:
Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning. Open, Classified |
IWB | K173791 |
| May 31, 2017 | Elekta, 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 |
IWB | K160440 |
| Apr 19, 2016 | Elekta, 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 |
IWB | K151159 K151561 |
| Jun 5, 2015 | Elekta, Inc. Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment. Terminated |
IWB | K103093 |
| Oct 30, 2014 | Elekta, Inc. Laksell Gamma Knife Perfexion Terminated |
IWB | K120811 |
| Nov 30, 2011 | Elekta, 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 |
IWB | K984328 |
| Nov 30, 2011 | Elekta, Inc. Elekta Leksell Gamma Plan
Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning. Terminated |
IWB | K973441 |
| Feb 14, 2011 | Elekta, Inc. Leksell GammaPlan, Model 5.34.
Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy. Terminated |
IWB | K973441 |
| Oct 28, 2010 | Elekta, Inc. Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden. Terminated |
IWB | K092083 |
| May 14, 2010 | Elekta, 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 |
IWB | K973441 |
| Apr 29, 2010 | Elekta, Inc. Leksell Gamma Knife C Terminated |
IWB | K984328 |
| Apr 27, 2010 | Elekta, 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 |
IWB | K973441 |
| Apr 22, 2010 | Elekta, Inc. Leksell Gamma Knife C Terminated |
IWB | K984328 |
| Apr 13, 2010 | Elekta, Inc. Leksell Gamma Knife.
Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures Terminated |
IWB | K984328 |
| Apr 5, 2010 | Elekta, 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 |
IWB | K063512 |
| Apr 5, 2010 | Elekta, Inc. Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA.
Indicated for use in the stereotactic irradiation of intracranial structures. Terminated |
IWB | K063512 |
| Apr 5, 2010 | Elekta, 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 |
IWB | K063512 |
| Mar 17, 2010 | Elekta, 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 |
IWB | K063512 |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron Elite 100 Cobalt Radiotherapy Terminated |
IWB | K983917 |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron Elite 80 Cobalt Radiotherapy Terminated |
IWB | K983917 |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron Phoenix Cobalt Radiotherapy Terminated |
IWB | K863180 |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron 1000E Cobalt Radiotherapy Terminated |
IWB | K964607 |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron 1000 Cobalt Radiotherapy Terminated |
IWB | K001006 |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron 780E Cobalt Radiotherapy Terminated |
IWB | K964606 |
| Jun 27, 2006 | MDS Canada Inc. DBA MDS Nordion Theratron 780C Cobalt Radiotherapy Terminated |
IWB | K001006 |
| Jan 18, 2006 | Varian 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 |
IWB | K010975 K023052 +1 |
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