Company ยท GB
Elekta, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2021. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
162recalls (11 in 12 months)
161recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IYE | Accelerator, Linear, Medical | 96 |
| MUJ | System, Planning, Radiation Therapy Treatment | 48 |
| IWB | System, Radiation Therapy, Radionuclide | 18 |
| HAW | Neurological Stereotaxic Instrument | 7 |
| JAI | Couch, Radiation Therapy, Powered | 6 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 4 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 3 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 11, 2021 | K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Elekta Limited, GB | IYE |
| Dec 5, 2019 | K192482 | Elekta Unity Elekta Limited, GB | IYE |
| Nov 22, 2019 | K192242 | Synergy Platform, Synergy, Infinity, VersaHD Elekta Limited, GB | IYE |
| Mar 29, 2019 | K190178 | Monaco RTP System Elekta, Inc. | MUJ |
| Dec 4, 2018 | K183037 | Monaco RTP System Elekta, Inc. | MUJ |
| Dec 4, 2018 | K183034 | MOSAIQ Oncology Information System Elekta, Inc. | IYE |
| Dec 4, 2018 | K182076 | Elekta Unity Elekta Limited, GB | IYE |
| Dec 11, 2015 | K153011 | iViewDose R1.0 Elekta Limited, GB | IYE |
| Oct 8, 2014 | K141855 | CLARITY Elekta , Ltd., CA | IYE |
| Sep 25, 2013 | K131965 | XVI R5.0 Elekta Limited, GB | IYE |
| Apr 4, 2013 | K123808 | AGILITY Elekta , Ltd., GB | IYE |
| Dec 5, 2012 | K121663 | CLARITY Elekta , Ltd., CA | IYE |
| Jun 12, 2012 | K121328 | AGILITY Elekta , Ltd., GB | IYE |
| Jan 30, 2012 | K111332 | CLARITY OBP SYSTEM Elekta , Ltd., CA | IYE |
| Dec 16, 2011 | K112613 | INTEGRITY(TM) Elekta Limited, GB | IYE |
| Sep 30, 2011 | K111676 | APEX Elekta Limited, GB | IXI |
| Nov 4, 2010 | K102200 | INTEGRITY MODEL 1014284 Elekta , Ltd., GB | IYE |
| Mar 10, 2010 | K100115 | XVI R4.5 Elekta , Ltd., GB | IYE |
| Aug 29, 2008 | K082122 | MLCI2 Elekta , Ltd., GB | IYE |
| Jun 11, 2008 | K080585 | DESKTOP PRO Elekta , Ltd., GB | IYE |
| Aug 12, 2005 | K051932 | ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 Elekta, Inc. | IYE |
| Jan 31, 2005 | K042794 | BEAM MODULATOR, MODEL 4513 332 8000 Elekta , Ltd. | IYE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2026 | Elekta, Inc. Brand Name: Geneva
Product Name: Brachytherapy Applicator
Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional n Open, Classified |
JAQ | K201272 |
| Jul 9, 2026 | Elekta, Inc. Brand Name: Brachytherapy Applicator
Product Name: Advanced Gynecological Applicator
Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for c Open, Classified |
JAQ | K161688 |
| Jul 9, 2026 | Elekta, Inc. Brand Name: Fletcher CT/MR Shielded Applicator Set
Product Name: Intracavitary Remote Afterloading Applicator
Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecologi Open, Classified |
JAQ | K132889 |
| Jun 11, 2026 | Elekta, Inc. MOSAIQ Oncology Information System Open, Classified |
IYE | K223229 |
| Apr 29, 2026 | Elekta, Inc. Brand Name: Leksell Vantage Arc System
REF: 1053958 Open, Classified |
HAW | K190887 |
| Mar 19, 2026 | Elekta, Inc. Brand Name: Leksell Gamma Knife
Product Description: Leksell Gamma Knife Perfexion
Leksell Gamma Knife Icon"
Leksell Gamma Knife Elekta Esprit
Leksell Gamma Knife (available models Elekta Esprit, Open, Classified |
IWB | K250391 |
| Feb 10, 2026 | Elekta, Inc. Brand Name: Leksell GammaPlan
Product Name: Radionuclide RT Treatment planning system
Software Version: 11,3, 11.4
Product Description: Leksell GammaPlan is a computer-based system designed for Leksel Open, Classified |
MUJ | K173791 |
| Feb 10, 2026 | Elekta, Inc. Brand Name: Leksell GammaPlan
Product Name: Radionuclide RT Treatment planning system
Software Version: 11.1
Product Description: Leksell GammaPlan is a computer-based system designed for Leksell Gamm Open, Classified |
MUJ | K151666 |
| Jan 23, 2026 | Elekta, Inc. Brand Name: Elekta Medical Linear Accelerator
Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
Software Version: N/A
Product Description: Digital Linear Accelerator
Component: N Open, Classified |
IYE | K210500 |
| Jan 13, 2026 | Elekta, Inc. MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) Open, Classified |
IYE | K203172 K223229 |
| Nov 5, 2025 | Elekta, Inc. Brand Name: Leksell Stereotactic System
Product Name: Leksell Vantage Stereotactic System
Software Version: n/a
Product Description: The Intended Purpose of Leksell Vantage" Stereotactic System is tar Open, Classified |
HAW | K190887 |
| Feb 12, 2025 | Elekta, Inc. MOSAIQ Oncology Information System Open, Classified |
IYE | K223229 |
| Dec 1, 2023 | Elekta, Inc. ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | K210500 |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | K210500 |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | K210500 |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | K210500 |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | K210500 |
| Dec 1, 2023 | Elekta, Inc. ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Open, Classified |
IYE | K210500 |
| Jun 2, 2023 | Elekta, Inc. Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil. Open, Classified |
IYE | K212114 |
| May 30, 2023 | Elekta, Inc. Elekta Medical Linear Accelerator (ELMA) included in the below platforms:
a. Elekta Infinity;
b. Versa HD;
c. Elekta Synergy Open, Classified |
IYE | K210500 |
| Mar 8, 2023 | Elekta Inc Monaco RTP System.
Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Open, Classified |
MUJ | K151233 |
| Dec 15, 2022 | Elekta, Inc. Oncentra Brachy radiation therapy planning system software. Open, Classified |
MUJ | K132816 |
| Oct 13, 2021 | Elekta, Inc. Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 Open, Classified |
MUJ | K132816 |
| Sep 17, 2021 | Elekta, Inc. Elekta Medical Linear Accelerator (EMLA), configured as follows:
a. Elekta Precise Digital Accelerator;
b. Elekta Harmony;
c. Elekta Synergy;
d. Elekta Infinity;
e. Versa HD Terminated |
IYE | K210500 |
| Sep 14, 2021 | Elekta Inc Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy. Open, Classified |
MUJ | K183037 K190178 |
| Sep 2, 2021 | Elekta, Inc. MOSAIQ Oncology Information System Open, Classified |
IYE | K183034 |
| Jul 26, 2021 | Elekta Inc Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 Open, Classified |
MUJ | K183037 K190178 |
| Apr 20, 2021 | Elekta, Inc. Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud Terminated |
IYE | K141572 K183034 |
| Jun 8, 2020 | Elekta Limited Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571 Terminated |
IYE | K192482 |
| Jun 5, 2020 | Elekta, Inc. Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign dis Terminated |
IYE | K192482 |
| Apr 29, 2020 | Elekta Inc Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument Terminated |
HAW | K171123 K190887 |
| Apr 16, 2020 | Elekta Inc Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation the Open, Classified |
MUJ | K183037 |
| Dec 18, 2019 | Elekta, Inc. Elekta Unity, Image-Guided Radiation Therapy System Terminated |
IYE | K192482 |
| Nov 22, 2019 | Elekta Inc Monaco Radiation Treatment Planning System (RTP) System Open, Classified |
MUJ | K183037 K190178 |
| Sep 4, 2019 | Elekta Inc Monaco RTP System, 5.50/5.51, radiation treatment planning system
Product Usage:
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. Open, Classified |
MUJ | K190178 |
| Sep 4, 2019 | Elekta Inc Monaco RTP System, 5.40 Unity, radiation treatment planning system
Product Usage:
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy Open, Classified |
MUJ | K183037 |
| Aug 23, 2019 | Elekta, Inc. Monaco Radiation Treatment Planning System (RTP) System Terminated |
MUJ | K190178 |
| Jul 16, 2019 | Elekta, Inc. Elekta Unity, Image-Guided Radiation Therapy System
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and Terminated |
IYE | K182076 |
| Jul 3, 2019 | Elekta Inc Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System Open, Classified |
MUJ | K151233 |
| Jun 19, 2019 | Elekta, Inc. iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 Terminated |
IYE | K072079 |
| May 8, 2019 | Elekta Limited Elekta Unity systems
Product Usage:
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases Terminated |
IYE | K182076 |
| Mar 12, 2019 | Elekta Limited Elekta Unity, Image-Guided Radiation Therapy System
Product Usage:
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of Terminated |
IYE | K182076 |
| Feb 8, 2019 | Elekta, Inc. Monaco Radiation Treatment Planning (RTP) System Terminated |
MUJ | K183037 |
| Jan 4, 2019 | Elekta Limited Elekta Unity Completed |
IYE | K182076 |
| Dec 13, 2018 | Elekta, Inc. MOSAIQ Oncology Information System and Sequencer
MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare f Open, Classified |
IYE | K120067 K123230 +2 |
| Dec 4, 2018 | Elekta, Inc. MOSAIQ Oncology Information System Version 2.64.
MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery Terminated |
IYE | K141572 |
| Aug 3, 2018 | Elekta, Inc. MOSAIQ Oncology Information System Terminated |
IYE | K141572 |
| May 16, 2018 | Elekta, Inc. HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system.
Product Usage:
To support and aid in positioning a patient during radiation therapy Terminated |
JAI | K072898 |
| Dec 1, 2017 | Elekta, Inc. ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD Terminated |
IYE | K051932 |
| Nov 20, 2017 | Elekta Limited Integrity R1.2 Terminated |
IYE | K112613 |
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