Elekta Limited
Atlanta, GA, US
ELEKTA LIMITED appears in FDA device records in Atlanta, GA. FDA records list 58 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 203 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Elekta Limited carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Computerized Medical Systems, Inc.510(k), recall
- Elekta Impac Softwareenforcement report, recall
- Impac Medical Systems, Inc.510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 58FDA records hold 58 510(k) clearances for Elekta Limited between 1985 and 2021. The busiest year on record is 2012, with 5. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 1 |
| 1991 | 3 |
| 1992 | 1 |
| 1995 | 2 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 3 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 2 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 2 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 5 |
| 2013 | 3 |
| 2014 | 2 |
| 2015 | 2 |
| 2018 | 3 |
| 2019 | 3 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD | IYE | Substantially Equivalent | |
| K192482 | Elekta Unity | IYE | Substantially Equivalent | |
| K192242 | Synergy Platform, Synergy, Infinity, VersaHD | IYE | Substantially Equivalent | |
| K190178 | Monaco RTP System | MUJ | Substantially Equivalent | |
| K183037 | Monaco RTP System | MUJ | Substantially Equivalent | |
| K183034 | MOSAIQ Oncology Information System | IYE | Substantially Equivalent | |
| K182076 | Elekta Unity | IYE | Substantially Equivalent | |
| K153011 | iViewDose R1.0 | IYE | Substantially Equivalent | |
| K151233 | Monaco | MUJ | Substantially Equivalent | |
| K141855 | CLARITY | IYE | Substantially Equivalent | |
| K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | IYE | Substantially Equivalent | |
| K132971 | MONACO | MUJ | Substantially Equivalent | |
| K131965 | XVI R5.0 | IYE | Substantially Equivalent | |
| K123808 | AGILITY | IYE | Substantially Equivalent | |
| K123230 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | IYE | Substantially Equivalent | |
| K121663 | CLARITY | IYE | Substantially Equivalent | |
| K121328 | AGILITY | IYE | Substantially Equivalent | |
| K120067 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | IYE | Substantially Equivalent | |
| K111332 | CLARITY OBP SYSTEM | IYE | Substantially Equivalent | |
| K112613 | INTEGRITY(TM) | IYE | Substantially Equivalent | |
| K111676 | APEX | IXI | Substantially Equivalent | |
| K110730 | MONACO RTP SYSTEM | MUJ | Substantially Equivalent | |
| K102200 | INTEGRITY MODEL 1014284 | IYE | Substantially Equivalent | |
| K102216 | XIO RTP SYSTEM | MUJ | Substantially Equivalent | |
| K100115 | XVI R4.5 | IYE | Substantially Equivalent | |
| K092132 | XIO RTP SYSTEM | MUJ | Substantially Equivalent | |
| K091179 | MONACO RTP SYSTEM, VMAT OPTION | MUJ | Substantially Equivalent | |
| K082122 | MLCI2 | IYE | Substantially Equivalent | |
| K080799 | ATLAS-BASED AUTOSEGMENTATION | LHN | Substantially Equivalent | |
| K080585 | DESKTOP PRO | IYE | Substantially Equivalent | |
| K071938 | MONACO RTP SYSTEM | MUJ | Substantially Equivalent | |
| K051932 | ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 | IYE | Substantially Equivalent | |
| K042794 | BEAM MODULATOR, MODEL 4513 332 8000 | IYE | Substantially Equivalent | |
| K043412 | MODIFICATION TO: VIEWSTATION | LLZ | Substantially Equivalent | |
| K032762 | XIO RADIATION TREATMENT PLANNING SYSTEM | IYE | Substantially Equivalent | |
| K032100 | I-BEAM | IYE | Substantially Equivalent | |
| K020027 | FOCUS RADIATION TREATMENT PLANNING SYSTEM | MUJ | Substantially Equivalent | |
| K013112 | FOCAL SIM | MUJ | Substantially Equivalent | |
| K013531 | QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 | KPQ | Substantially Equivalent | |
| K011694 | VIEWSTATION | LLZ | Substantially Equivalent | |
| K002147 | FOCUS | MUJ | Substantially Equivalent | |
| K000137 | ENHANCED COMPENSATING FILTER | IXI | Substantially Equivalent | |
| K991133 | MLC FIT | IYE | Substantially Equivalent | |
| K981535 | FOCUS PILOT CONTOURING WORKSTATION | IYE | Substantially Equivalent | |
| K981313 | SEQUENCER | IYE | Substantially Equivalent | |
| K973936 | FOCUS RTP SYSTEM | IYE | Substantially Equivalent | |
| K962335 | MLC FIT | IYE | Substantially Equivalent | |
| K942346 | IMAGERT | IYE | Substantially Equivalent | |
| K915691 | FOCUS RTP | MUJ | Substantially Equivalent | |
| K921108 | CMS RECORD AND VERIFY | KPQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9617016 | 3002806900 | ELEKTA LIMITED | Cornerstone, CRAWLEY West Sussex RH10 9BL GB | 2026 | |
| 1037831 | 1037831 | ELEKTA, INC | 400 Perimeter Center Ter Ne Ste 50, Atlanta, GA 30346 US | 2026 | No device listings on this registration |
| 3032638959 | 3032638959 | Elekta Inc. | 101 Nicholson Ln, San Jose, CA 95134 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- IXIBlock, Beam-Shaping, Radiation Therapy
- DPSElectrocardiograph
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- 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
Recall records
Showing 25 of 203| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2406-2026 | MOSAIQ Oncology Information System | Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. | Class II | Open, Classified | |
| Z-2712-2026 | 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 needles can be placed for interstitial therapy. | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. | Class II | Open, Classified | |
| Z-2711-2026 | Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy. | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. | Class II | Open, Classified | |
| Z-2710-2026 | 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 gynecological brachytherapy treatment of the cervix and endometrium. | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. | Class II | Open, Classified | |
| Z-2006-2026 | Brand Name: Leksell Vantage Arc System REF: 1053958 | Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. | Class II | Open, Classified | |
| Z-1581-2026 | 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, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target. | Due to adapter not being properly aligned or locked in place. | Class II | Open, Classified | |
| Z-1164-2026 | 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: No | Due to a manufacturing issue and electrical grounding of systems. | Class II | Open, Classified | |
| Z-1340-2026 | 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 Leksell Gamma Knife treatment planning. | Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users. | Class II | Open, Classified | |
| Z-1339-2026 | 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 Gamma Knife treatment planning. | Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users. | Class II | Open, Classified | |
| Z-1078-2026 | MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) | Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice | Class II | Open, Classified | |
| Z-0433-2026 | 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 target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments. | Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound | Class II | Open, Classified | |
| Z-1162-2025 | MOSAIQ Oncology Information System | Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale. | Class II | Open, Classified | |
| Z-0447-2024 | ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension. | Class II | Open, Classified | |
| Z-0446-2024 | ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension. | Class II | Open, Classified | |
| Z-0445-2024 | ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension. | Class II | Open, Classified | |
| Z-0444-2024 | ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension. | Class II | Open, Classified | |
| Z-0443-2024 | ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension. | Class II | Open, Classified | |
| Z-0442-2024 | ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension. | Class II | Open, Classified | |
| Z-1665-2023 | Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy | A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601 | Class II | Open, Classified | |
| Z-1675-2023 | Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil. | There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems. | Class II | Open, Classified | |
| Z-1233-2023 | Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy. | Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation. | Class II | Open, Classified | |
| Z-0719-2023 | Oncentra Brachy radiation therapy planning system software. | A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling | Class II | Open, Classified | |
| Z-0182-2022 | Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 | Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels. | Class II | Open, Classified | |
| Z-0116-2022 | 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 | 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 | |
| Z-2563-2021 | Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy. | Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain