Elekta Solutions AB
Stockholm, SE
ELEKTA SOLUTIONS AB appears in FDA device records in Stockholm, SE. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Elekta Solutions AB between 2020 and 2026. The busiest year on record is 2021, with 3. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261932 | Leksell® Vantage Stereotactic System | HAW | Substantially Equivalent | |
| K252002 | Monaco RTP System (6.3) | MUJ | Substantially Equivalent | |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | IYE | Substantially Equivalent | |
| K251363 | ProKnow DS | LLZ | Substantially Equivalent | |
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) | IWB | Substantially Equivalent | |
| K232854 | Leksell GammaPlan (LGP) | IWB | Substantially Equivalent | |
| K223233 | Monaco RTP System | MUJ | Substantially Equivalent | |
| K223229 | MOSAIQ® OIS (Oncology Information System) | IYE | Substantially Equivalent | |
| K223209 | Elekta Unity | IYE | Substantially Equivalent | |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | IWB | Substantially Equivalent | |
| K213787 | Monaco RTP System | MUJ | Substantially Equivalent | |
| K212218 | Advanced Algorithms for Treatment Management Applications (AATMA) | QKB | Substantially Equivalent | |
| K212114 | Elekta Unity | IYE | Substantially Equivalent | |
| K202789 | Monaco Rtp System | MUJ | Substantially Equivalent | |
| K203172 | MOSAIQ Oncology Information System | IYE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015232217 | 3015232217 | ELEKTA SOLUTIONS AB | Hagaplan 4, STOCKHOLM 11368 SE | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- IXIBlock, Beam-Shaping, Radiation Therapy
- IYXCamera, Scintillation (Gamma)
- JAICouch, Radiation Therapy, Powered
- FRZDevice, Patient Transfer, Powered
- LHOInstrument, Quality-Assurance, Radiologic
- OWBInterventional Fluoroscopic X-Ray System
- HAWNeurological Stereotaxic Instrument
- FWZOperating Room Accessories Table Tray
- QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation
- QKBRadiological Image Processing Software For Radiation Therapy
- JAQSystem, Applicator, Radionuclide, Remote-Controlled
- LLZSystem, Image Processing, Radiological
- LNHSystem, Nuclear Magnetic Resonance Imaging
- MUJSystem, Planning, Radiation Therapy Treatment
- LHNSystem, Radiation Therapy, Charged-Particle, Medical
- IWBSystem, Radiation Therapy, Radionuclide
- KPQSystem, Simulation, Radiation Therapy
- JADSystem, Therapeutic, X-Ray
- KPSSystem, Tomography, Computed, Emission
- IZISystem, X-Ray, Angiographic
- JAKSystem, X-Ray, Tomography, Computed
- IXQTable, Radiographic, Stationary Top
- OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0503-2026 | MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)3.2.1.4 3.2.2.0 (01)07340201500071(10)3.2.2.0 3.2.2.1 (01)07340201500071(10)3.2.2.1 3.2.3.0 (01)07340201500071(10)3.2.3.0 MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. | When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule. | Class II | Open, Classified | |
| Z-0115-2022 | Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093. | There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain