Leksell Gamma Knife Perfexion
FDA 510(k) K120811 · Elekta Instrument AB
510(k) numberK120811
Submission
- Device name
- Leksell Gamma Knife Perfexion
- Applicant
- Elekta Instrument AB
Stockholm, SE - Received
- March 16, 2012
- Decision date
- May 24, 2012
- 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 |
| K232854 | Leksell GammaPlan (LGP)IWB · Traditional | Elekta Solutions AB | 02/08/2024SE |
| 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 |
More from Elekta Instrument AB
| 510(k) | Device | Decision |
|---|---|---|
| K190887 | Leksell Vantage Stereotactic SystemHAW · Traditional | 08/01/2019SE |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconIWB · Traditional | 03/30/2018SE |
| K173791 | Leksell GammaPlanIWB · Traditional | 02/09/2018SE |
| K171123 | Leksell Vantage Stereotactic SystemHAW · Traditional | 09/15/2017SE |
| K160440 | Leksell Gamma Knife IconIWB · Traditional | 04/20/2016SE |
| K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle KitHAW · Special | 03/02/2016SE |
| K151159 | Leksell Gamma Knife PerfexionIWB · Traditional | 10/29/2015SE |
| K151666 | Leksell GammaPlanMUJ · Traditional | 09/03/2015SE |
| K151561 | Leksell Gamma Knife IconIWB · Traditional | 08/04/2015SE |
| K133565 | Leksell Gamma Knife PerfexionIWB · Traditional | 05/09/2014SE |
Questions and answers
When was Leksell Gamma Knife Perfexion cleared by the FDA?
Leksell Gamma Knife Perfexion (K120811) received a 510(k) decision of Substantially Equivalent on May 24, 2012, 69 days after the submission was received.
What is the product code of K120811?
The FDA product code is IWB – System, Radiation Therapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5750.