Couch, Radiation Therapy, Powered
Regulation 892.5770
0510(k)s in 12 months (32 all time)
0recalls in 12 months (18 all time)
18recalls that name a 510(k)
Top companies in JAI
| Company | 510(k)s | Recalls |
|---|---|---|
| Elekta, Inc. | 0 | 6 |
| Siemens Medical Solutions USA, Inc. | 2 | 3 |
| Accuray Incorporated | 1 | 3 |
| Med-Tec,Inc. | 2 | 2 |
| Brainlab AG | 2 | 1 |
| Forte Automation Systems, Inc. | 2 | 1 |
| Medical Intelligence Medizintechnik GmbH | 3 | 0 |
| Nomos Corp. | 3 | 0 |
| LEONI CIA CABLE SYSTEMS | 0 | 2 |
| Med-Tec, Inc. D/B/A Civco Medical Solutions | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2023 | LEONI CIA CABLE SYSTEMS ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment.
Part Numbe Open, Classified |
JAI | K160518 |
| Nov 21, 2023 | LEONI CIA CABLE SYSTEMS ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment.
Part Numbe Open, Classified |
JAI | K160518 |
| 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 |
| Nov 8, 2017 | Med Tec Inc Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, Terminated |
JAI | K132084 |
| Sep 5, 2017 | Forte Automation Systems Inc Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10
Product Usage:
The patient positioning system is a SCARA designed robotic arm designed to position a patient for Terminated |
JAI | K122413 |
| Mar 31, 2016 | Med Tec Inc Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041 Terminated |
JAI | K132084 |
| Mar 19, 2015 | Elekta, Inc. Elekta Precise Treatment Table Terminated |
JAI | K983678 |
| Apr 25, 2014 | Elekta, Inc. HexaPOD evo RT Couchtop.
To support and aid in positioning a patient during radiation therapy. Terminated |
JAI | K072898 |
| Jan 17, 2014 | Siemens Medical Solutions USA, Inc PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table.
TT-A, TT-D, TT-M or TT-S Table tops.
Manufactured by:
SIEMENS AG, MEDICAL SOLUTIONS
Roentgenstrasse 19-21
Kemnath, GERM Terminated |
JAI | K050422 |
| Apr 20, 2013 | Accuray Incorporated RoboCouch Patient Positioning System
Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when Terminated |
JAI | K042146 |
| Apr 9, 2013 | Elekta, Inc. Precise Treatment Table.
To be used as part of radiation therapy treatment process. Terminated |
JAI | K983678 |
| Apr 19, 2011 | Siemens Medical Solutions USA, Inc Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufactured and distributed by Siemens AG, Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany 95478.
The 550 Tx Terminated |
JAI | K050422 |
| Feb 3, 2011 | Elekta, Inc. Precise Treatment Table
The Precise Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Ele Terminated |
JAI | K983678 |
| Jan 11, 2011 | Accuray Inc RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA.
Intended for use in the support Terminated |
JAI | K042146 K072504 |
| Oct 28, 2010 | Siemens Medical Solutions USA, Inc Siemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured by Siemens AG, Medical Solutions, Germany Terminated |
JAI | K050422 |
| Apr 23, 2010 | Elekta, Inc. Precise Treatment Table
Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. Terminated |
JAI | K983678 |
| Jan 14, 2009 | Accuray Inc RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007, manufactured by Accuray Inc., Sunnyvale, CA
The CyberKnife is indicated for treatment Terminated |
JAI | K042146 |
| Jul 27, 2006 | Brainlab AG ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System; Terminated |
JAI | K033316 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.