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Panels › Radiology › Product code JAI · Class 2

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)
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Top companies in JAI

Company510(k)sRecalls
Elekta, Inc.06
Siemens Medical Solutions USA, Inc.23
Accuray Incorporated13
Med-Tec,Inc.22
Brainlab AG21
Forte Automation Systems, Inc.21
Medical Intelligence Medizintechnik GmbH30
Nomos Corp.30
LEONI CIA CABLE SYSTEMS02
Med-Tec, Inc. D/B/A Civco Medical Solutions20
DateFirm and productCodeLinked 510(k)
Nov 21, 2023LEONI 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
JAIK160518
Nov 21, 2023LEONI 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
JAIK160518
May 16, 2018Elekta, 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
JAIK072898
Nov 8, 2017Med 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
JAIK132084
Sep 5, 2017Forte 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
JAIK122413
Mar 31, 2016Med 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
JAIK132084
Mar 19, 2015Elekta, Inc.
Elekta Precise Treatment Table
Terminated
JAIK983678
Apr 25, 2014Elekta, Inc.
HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.
Terminated
JAIK072898
Jan 17, 2014Siemens 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
JAIK050422
Apr 20, 2013Accuray 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
JAIK042146
Apr 9, 2013Elekta, Inc.
Precise Treatment Table. To be used as part of radiation therapy treatment process.
Terminated
JAIK983678
Apr 19, 2011Siemens 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
JAIK050422
Feb 3, 2011Elekta, 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
JAIK983678
Jan 11, 2011Accuray 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
JAIK042146
K072504
Oct 28, 2010Siemens 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
JAIK050422
Apr 23, 2010Elekta, Inc.
Precise Treatment Table Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use.
Terminated
JAIK983678
Jan 14, 2009Accuray 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
JAIK042146
Jul 27, 2006Brainlab 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
JAIK033316

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