JAI · Couch, Radiation Therapy, Powered
Radiology · 21 CFR 892.5770 · Class 2
Overview
| Product Code | JAI |
|---|---|
| Device Name | Couch, Radiation Therapy, Powered |
| Regulation | 21 CFR 892.5770 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231612 | Eve Patient Positioner System | Leo Cancer Care | May 7, 2024 | SESE |
| K182683 | Z-Robot Patient Positioning System | Chinan Biomedical Technology, Inc. | Jun 27, 2019 | SESE |
| K170502 | Patient Positioning System | Forte Automation Systems, Inc. | Apr 13, 2017 | SESE |
| K160518 | LEONI ORION System | Leoni Cia Cable System | Jul 14, 2016 | SESE |
| K132084 | PROTURA COUCH SOFTWARE | Med-Tec, Inc. D/B/A Civco Medical Solutions | Sep 26, 2013 | SESE |
| K122413 | PATIENT POSITIONING SYSTEM | Forte Automation Systems, Inc. | Sep 13, 2012 | SESE |
| K122201 | PROTURA COUCH SOFTWARE | Med-Tec, Inc. D/B/A Civco Medical Solutions | Aug 30, 2012 | SESE |
| K120520 | EXACTRAC ROBOTICS NOVALIS ROBOTICS | Brainlab AG | Jun 29, 2012 | SESE |
| K120916 | QFIX RADIOTHERAPY CHAIR | Wfr/Aquaplast Corp. | Jun 20, 2012 | SESE |
| K072898 | HEXAPOD EVO RT COUCH TOP | Medical Intelligence Medizintechnik GmbH | Oct 25, 2007 | SESE |
| K071870 | HEXAPOD RT COUCH TOP | Medical Intelligence Medizintechnik GmbH | Jul 8, 2007 | SESE |
| K062639 | MODIFICATION TO HEXAPOD RT COUCH TOP | Medical Intelligence Medizintechnik-GmbH-An Elekta | Sep 21, 2006 | SESE |
| K060870 | AVANZA | Mds Nordion | May 15, 2006 | SESE |
| K060671 | KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS | Wfr/Aquaplast Corp. | May 4, 2006 | SESE |
| K050422 | 550 TXT TREATMENT TABLE | Siemens Medical Solutions USA, Inc. | Mar 18, 2005 | SESE |
| K042146 | ROBOCOUCH PATIENT SUPPORT SYSTEM | Accuray Incorporated | Sep 17, 2004 | SESE |
| K041448 | HEXAPOD RT COUCHTOP | Medical Intelligence Medizintechnik GmbH | Jun 16, 2004 | SESE |
| K033316 | TABLE TILT DEVICE | Brainlab AG | May 14, 2004 | SESE |
| K034054 | PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 | Med-Tec,Inc. | Feb 20, 2004 | SESE |
| K031866 | MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC | Med-Tec,Inc. | Aug 14, 2003 | SESE |
Top Applicants
- Medical Intelligence Medizintechnik GmbH — 3 clearances
- Nomos Corp. — 3 clearances
- Brainlab AG — 2 clearances
- Forte Automation Systems, Inc. — 2 clearances
- Med-Tec, Inc. D/B/A Civco Medical Solutions — 2 clearances
