510(k) K150191
- Device
- GammaBeam 500
- Applicant
- Best Theratronics Limited
- 510(k) number
- K150191
- Product code
- IWB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-17
- Date received
- 2015-01-28
- Regulation
- 892.5750
- Classification name
- System, Radiation Therapy, Radionuclide
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Mike de van der Schueren
- Address
- 413 March Rd. Ottawa CA k2k 0e4 k2k 0e4
FDA Registration Numbers#
- 1038814
- 3005136058
- 9617016
- 3014273653
- 3015232217
- 3020999824
- 9612186
- 3006946288
- 3015621321
- 3015620182
- 2939248
Source Documents#
Other 510(k) Records For Product Code IWB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) | Elekta Solutions AB | 2025-07-02 |
| K232854 | Leksell GammaPlan (LGP) | Elekta Solutions AB | 2024-02-08 |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | Elekta Solutions AB | 2022-10-26 |
| K203250 | TaiChiC | Our United Corporation | 2021-03-12 |
| K203146 | Akesis Galaxy RTi | Akesis, Inc. | 2021-03-05 |
| K200050 | Akesis Galaxy RTx | Akesis, Inc. | 2020-02-04 |
| K190844 | Akesis Galaxy | Akesis, Inc. | 2019-09-04 |
| K180571 | GammaPod | Xcision Medical Systems, LLC | 2018-04-04 |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | 2018-03-30 |
| K173791 | Leksell GammaPlan | Elekta Instrument AB | 2018-02-09 |
| K172706 | GammaPod - Model A | Xcision Medical Systems, LLC | 2017-12-22 |
| K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016-04-20 |
| K151159 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2015-10-29 |
| K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015-08-04 |
| K142219 | GammaBeam 100 | Best Theratronics Limited | 2014-11-13 |
Legacy Summary#
summary
FDA Review#
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