Leksell GammaPlan (LGP)
FDA 510(k) K232854 · Elekta Solutions AB
510(k) numberK232854
Submission
- Device name
- Leksell GammaPlan (LGP)
- Applicant
- Elekta Solutions AB
Stockholm, SE - Received
- September 15, 2023
- Decision date
- February 8, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife®…IWB · Traditional | Elekta Solutions AB | 07/02/2025SE |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…IWB · Traditional | Elekta Solutions AB | 10/26/2022SE |
| K203250 | TaiChiCIWB · Traditional | Our United Corporation | 03/12/2021SE |
| K203146 | Akesis Galaxy RTiIWB · Traditional | Akesis, Inc. | 03/05/2021SE |
| K200050 | Akesis Galaxy RTxIWB · Special | Akesis, Inc. | 02/04/2020SE |
| K190844 | Akesis GalaxyIWB · Traditional | Akesis, Inc. | 09/04/2019SE |
| K180571 | GammaPodIWB · Special | Xcision Medical Systems, LLC | 04/04/2018SE |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconIWB · Traditional | Elekta Instrument AB | 03/30/2018SE |
| K173791 | Leksell GammaPlanIWB · Traditional | Elekta Instrument AB | 02/09/2018SE |
| K172706 | GammaPod - Model AIWB · Traditional | Xcision Medical Systems, LLC | 12/22/2017SE |
More from Xcision Medical Systems, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | 08/05/2026SE |
| K252002 | Monaco RTP System (6.3)MUJ · Traditional | 02/19/2026SE |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…IYE · Traditional | 01/15/2026SE |
| K251363 | ProKnow DSLLZ · Traditional | 10/08/2025SE |
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife®…IWB · Traditional | 07/02/2025SE |
| K223233 | Monaco RTP SystemMUJ · Traditional | 02/23/2023SE |
| K223229 | MOSAIQ® OIS (Oncology Information System)IYE · Traditional | 02/23/2023SE |
| K223209 | Elekta UnityIYE · Traditional | 02/23/2023SE |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…IWB · Traditional | 10/26/2022SE |
| K213787 | Monaco RTP SystemMUJ · Traditional | 05/17/2022SE |
Questions and answers
When was Leksell GammaPlan (LGP) cleared by the FDA?
Leksell GammaPlan (LGP) (K232854) received a 510(k) decision of Substantially Equivalent on February 8, 2024, 146 days after the submission was received.
What is the product code of K232854?
The FDA product code is IWB – System, Radiation Therapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5750.