Leksell GammaPlan
FDA 510(k) K151666 · Elekta Instrument AB
510(k) numberK151666
Submission
- Device name
- Leksell GammaPlan
- Applicant
- Elekta Instrument AB
Stockholm, SE - Received
- June 19, 2015
- Decision date
- September 3, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MUJ
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|---|---|---|---|
| K260750 | Virtual Cone (1.0)MUJ · Traditional | Varian Medical Systems, Inc. | 07/08/2026SE |
| K253050 | RadOncAIMUJ · Traditional | Informai | 06/18/2026SE |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ · Traditional | Philips Medical Systems Nederland B.V. | 05/27/2026SE |
| K252784 | eXaSkin PlusMUJ · Traditional | Anatomical Geometry S.L. | 05/22/2026SE |
| K253078 | ART.1-USMUJ · Traditional | Seetreat Pty, Ltd. | 05/14/2026SE |
| K252304 | syngo.via RT Image Suite VC10MUJ · Traditional | Varian Medical Systems, Inc. | 03/18/2026SE |
| K260308 | TrueFit BolusMUJ · Special | Adaptiiv Medical Technologies, Inc. | 02/19/2026SE |
| K252002 | Monaco RTP System (6.3)MUJ · Traditional | Elekta Solutions AB | 02/19/2026SE |
| K253091 | ART-Plan+ (v3.1.0)MUJ · Traditional | Therapanacea Sas | 12/23/2025SE |
| K252109 | RayStation (2024A SP3)MUJ · Traditional | RaySearch Laboratories AB (PUBL) | 12/22/2025SE |
More from RaySearch Laboratories AB (PUBL)
| 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 |
| K151561 | Leksell Gamma Knife IconIWB · Traditional | 08/04/2015SE |
| K133565 | Leksell Gamma Knife PerfexionIWB · Traditional | 05/09/2014SE |
| K120811 | Leksell Gamma Knife PerfexionIWB · Traditional | 05/24/2012SE |
Questions and answers
When was Leksell GammaPlan cleared by the FDA?
Leksell GammaPlan (K151666) received a 510(k) decision of Substantially Equivalent on September 3, 2015, 76 days after the submission was received.
What is the product code of K151666?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.