Couch, Radiation Therapy, Powered
FDA product code JAI · Class II (moderate risk) · 21 CFR 892.5770 · Radiology
32510(k) clearances
0PMA approvals
17recalls
Manufacturers
- Nomos Corp. 3
- Medical Intelligence Medizintechnik GmbH 3
- Siemens Medical Solutions USA, Inc. 2
- Forte Automation Systems, Inc. 2
- Med-Tec, Inc. D/B/A Civco Medical Solutions 2
- Wfr/Aquaplast Corp. 2
- Med Tec Inc 2
- Brainlab AG 2
- Leo Cancer Care 1
- Atomic Energy of Canada 1
- Leoni Cia Cable System 1
- Medical Intelligence Medizintechnik-GmbH-An Elekta 1
- Mds Nordion 1
- Accuray Incorporated 1
- Aktina Medical Physics Corp. 1
- Elekta Instruments, Inc. 1
- American Biophysics, Inc. 1
- Radiation Technology, Inc. 1
- The Complete Systems Corp. Genesys 1
- Siemens Medical Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231612 | Eve Patient Positioner SystemJAI · Traditional | Leo Cancer Care | 05/07/2024SE |
| K182683 | Z-Robot Patient Positioning SystemJAI · Traditional | Chinan Biomedical Technology, Inc. | 06/27/2019SE |
| K170502 | Patient Positioning SystemJAI · Special | Forte Automation Systems, Inc. | 04/13/2017SE |
| K160518 | LEONI ORION SystemJAI · Traditional | Leoni Cia Cable System | 07/14/2016SE |
| K132084 | Protura Couch SoftwareJAI · Traditional | Med-Tec, Inc. D/B/A Civco Medical Solutions | 09/26/2013SE |
| K122413 | Patient Positioning SystemJAI · Traditional | Forte Automation Systems, Inc. | 09/13/2012SE |
| K122201 | Protura Couch SoftwareJAI · Traditional | Med-Tec, Inc. D/B/A Civco Medical Solutions | 08/30/2012SE |
| K120520 | Exactrac Robotics Novalis RoboticsJAI · Traditional | Brainlab AG | 06/29/2012SE |
| K120916 | Qfix Radiotherapy ChairJAI · Traditional | Wfr/Aquaplast Corp. | 06/20/2012SE |
| K072898 | Hexapod Evo RT Couch TopJAI · Special | Medical Intelligence Medizintechnik GmbH | 10/25/2007SE |
| K071870 | Hexapod RT Couch TopJAI · Special | Medical Intelligence Medizintechnik GmbH | 07/08/2007SE |
| K062639 | Modification to Hexapod RT Couch TopJAI · Special | Medical Intelligence Medizintechnik-GmbH-An Elekta | 09/21/2006SE |
| K060870 | AvanzaJAI · Traditional | Mds Nordion | 05/15/2006SE |
| K060671 | Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, VariousJAI · Traditional | Wfr/Aquaplast Corp. | 05/04/2006SE |
| K050422 | 550 TXT Treatment TableJAI · Special | Siemens Medical Solutions USA, Inc. | 03/18/2005SE |
| K042146 | Robocouch Patient Support SystemJAI · Traditional | Accuray Incorporated | 09/17/2004SE |
| K041448 | Hexapod RT CouchtopJAI · Traditional | Medical Intelligence Medizintechnik GmbH | 06/16/2004SE |
| K033316 | Table Tilt DeviceJAI · Traditional | Brainlab AG | 05/14/2004SE |
| K034054 | Pro Series Couch Software, Model MT-PRO100JAI · Traditional | Med-Tec,Inc. | 02/20/2004SE |
| K031866 | Med-Tec 6 Degree Axis Couch, Model MT-6DACJAI · Traditional | Med-Tec,Inc. | 08/14/2003SE |
| K013036 | Nomos Motorized Crane IIJAI · Traditional | Nomos Corp. | 12/07/2001SE |
| K993522 | Aktina Medical Physics Corporation Tennis Racquet InsertJAI · Traditional | Aktina Medical Physics Corp. | 01/10/2000SE |
| K983678 | Elekta Oncology Systems Precise Treatment TableJAI · Traditional | Elekta Instruments, Inc. | 01/15/1999SE |
| K982446 | Dynamic Shielding Radiation TableJAI · Traditional | American Biophysics, Inc. | 09/29/1998SE |
| K964740 | The Nomos MinicraneJAI · Traditional | Nomos Corp. | 02/11/1997SE |
| K941927 | The Nomos CraneJAI · Traditional | Nomos Corp. | 02/09/1995SE |
| K910648 | Therapy Chair SystemJAI · Traditional | Radiation Technology, Inc. | 07/22/1991SE |
| K910002 | Genesys and the RoiJAI · Traditional | The Complete Systems Corp. Genesys | 07/22/1991SE |
| K910971 | Z XT Radiation Therapy Treatment TableJAI · Traditional | Siemens Medical Laboratories, Inc. | 05/03/1991SE |
| K855063 | Universal Patient Chair Uni 2000XJAI · Traditional | Siemens Medical Solutions USA, Inc. | 01/30/1986SE |
| K834201 | TCT-1 Treatment CouchJAI · Traditional | Therados, Inc. | 03/05/1984SE |
| K837152 | Therac 25 Linear AcceleratorJAI · Traditional | Atomic Energy of Canada | 03/22/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0399-2024 Class II | ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for…Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or… | Leoni Cia Cable Systems | 10/06/2023Open, Classified |
| Z-0398-2024 Class II | ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for…Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or… | Leoni Cia Cable Systems | 10/06/2023Open, Classified |
| Z-2535-2018 Class II | HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD…Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the… | Elekta, Inc. | 05/16/2018Terminated |
| Z-0671-2018 Class II | Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1…When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal… | Med Tec Inc | 11/08/2017Terminated |
| Z-2537-2018 Class II | Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10…Communications between the Patient Positioning System and the accuracy filter can periodically fail with no… | Forte Automation Systems Inc | 09/05/2017Terminated |
| Z-1992-2016 Class II | Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0…When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be… | Med Tec Inc | 03/31/2016Terminated |
| Z-1238-2015 Class II | Elekta Precise Treatment TableIt is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed… | Elekta, Inc. | 01/29/2015Terminated |
| Z-1514-2014 Class II | HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation…If screws are not properly tightened with a torque wrench they may become loose over time. | Elekta, Inc. | 04/17/2014Terminated |
| Z-0787-2014 Class II | PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D…Update to correct the possibility for patients or operators to have their fingers trapped or pinched between… | Siemens Medical Solutions USA, Inc | 12/05/2013Terminated |
| Z-1155-2013 Class II | RoboCouch Patient Positioning System Product Usage: is intended for use in the support…A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the… | Accuray Incorporated | 03/27/2013Terminated |
| Z-1072-2013 Class II | Precise Treatment Table. To be used as part of radiation therapy treatment process.The Column rotation can accidentally be moved to a different position which in the locked position. | Elekta, Inc. | 03/14/2013Terminated |
| Z-2023-2011 | Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is…Potential for causing overheating of the power supply during treatment, and potential for unexpected table… | Siemens Medical Solutions USA, Inc | 03/31/2010Terminated |
| Z-0166-2011 | Siemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or…An increase in voltage may cause a short circuit of a power transistor that may cause a smoldering and… | Siemens Medical Solutions USA, Inc | 03/31/2010Terminated |
| Z-0853-2011 | RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife…Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches. | Accuray Inc | 07/21/2009Terminated |
| Z-0856-2009 | RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery…Product may not be tensioned properly, potentially causing unexpected rotation or descent. | Accuray Inc | 10/30/2008Terminated |
| Z-1030-2011 | Precise Treatment Table The Precise Treatment Table is intended as a universal patient…Possible error in the table longitudinal position. | Elekta, Inc. | 03/10/2008Terminated |
| Z-1432-2010 | Precise Treatment Table Intended as a universal patient treatment support and…In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to… | Elekta, Inc. | 01/11/2007Terminated |