Leksell® Vantage Stereotactic System
FDA 510(k) K261932 · Elekta Solutions AB
510(k) numberK261932
Submission
- Device name
- Leksell® Vantage Stereotactic System
- Applicant
- Elekta Solutions AB
Stockholm, SE - Received
- June 9, 2026
- Decision date
- August 5, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
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| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…HAW · Traditional | Brainlab AG | 01/28/2025SE |
More from Brainlab AG
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| 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 |
| K232854 | Leksell GammaPlan (LGP)IWB · Traditional | 02/08/2024SE |
| 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® Vantage Stereotactic System cleared by the FDA?
Leksell® Vantage Stereotactic System (K261932) received a 510(k) decision of Substantially Equivalent on August 5, 2026, 57 days after the submission was received.
What is the product code of K261932?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.