Product code JAI
- Device name
- Couch, Radiation Therapy, Powered
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.5770
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231612 | Eve Patient Positioner System | Leo Cancer Care | 2024-05-07 |
| K182683 | Z-Robot Patient Positioning System | Chinan Biomedical Technology, Inc. | 2019-06-27 |
| K170502 | Patient Positioning System | Forte Automation Systems, Inc. | 2017-04-13 |
| K160518 | LEONI ORION System | Leoni Cia Cable System | 2016-07-14 |
| K132084 | PROTURA COUCH SOFTWARE | Med-Tec, Inc. D/B/A Civco Medical Solutions | 2013-09-26 |
| K122413 | PATIENT POSITIONING SYSTEM | Forte Automation Systems, Inc. | 2012-09-13 |
| K122201 | PROTURA COUCH SOFTWARE | Med-Tec, Inc. D/B/A Civco Medical Solutions | 2012-08-30 |
| K120520 | EXACTRAC ROBOTICS NOVALIS ROBOTICS | Brainlab AG | 2012-06-29 |
| K120916 | QFIX RADIOTHERAPY CHAIR | Wfr/Aquaplast Corp. | 2012-06-20 |
| K072898 | HEXAPOD EVO RT COUCH TOP | Medical Intelligence Medizintechnik GmbH | 2007-10-25 |
| K071870 | HEXAPOD RT COUCH TOP | Medical Intelligence Medizintechnik GmbH | 2007-07-08 |
| K062639 | MODIFICATION TO HEXAPOD RT COUCH TOP | Medical Intelligence Medizintechnik-GmbH-An Elekta | 2006-09-21 |
| K060870 | AVANZA | Mds Nordion | 2006-05-15 |
| K060671 | KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS | Wfr/Aquaplast Corp. | 2006-05-04 |
| K050422 | 550 TXT TREATMENT TABLE | Siemens Medical Solutions USA, Inc. | 2005-03-18 |
| K042146 | ROBOCOUCH PATIENT SUPPORT SYSTEM | Accuray Incorporated | 2004-09-17 |
| K041448 | HEXAPOD RT COUCHTOP | Medical Intelligence Medizintechnik GmbH | 2004-06-16 |
| K033316 | TABLE TILT DEVICE | Brainlab AG | 2004-05-14 |
| K034054 | PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 | Med-Tec,Inc. | 2004-02-20 |
| K031866 | MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC | Med-Tec,Inc. | 2003-08-14 |
| K013036 | NOMOS MOTORIZED CRANE II | Nomos Corp. | 2001-12-07 |
| K993522 | AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT | Aktina Medical Physics Corp. | 2000-01-10 |
| K983678 | ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE | Elekta Instruments, Inc. | 1999-01-15 |
| K982446 | DYNAMIC SHIELDING RADIATION TABLE | American Biophysics, Inc. | 1998-09-29 |
| K964740 | THE NOMOS MINICRANE | Nomos Corp. | 1997-02-11 |
| K941927 | THE NOMOS CRANE | Nomos Corp. | 1995-02-09 |
| K910002 | GENESYS AND THE ROI | The Complete Systems Corp. Genesys | 1991-07-22 |
| K910648 | THERAPY CHAIR SYSTEM | Radiation Technology, Inc. | 1991-07-22 |
| K910971 | Z XT RADIATION THERAPY TREATMENT TABLE | Siemens Medical Laboratories, Inc. | 1991-05-03 |
| K855063 | UNIVERSAL PATIENT CHAIR UNI 2000X | Siemens Medical Solutions USA, Inc. | 1986-01-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10841962119426 | Leg Extension | Qfix | 2023-05-05 |
| 10841962119419 | Applicator Clamp Holder | Qfix | 2023-05-05 |
| 10841962119402 | Applicator Clamp Holder | Qfix | 2023-05-05 |
| 10841962118733 | Iris AirShuttle™ | Qfix | 2023-04-10 |
| 10841962118726 | Encompass™ SRS Fibreplast® Anterior Mask | Qfix | 2021-12-21 |
| 10841962111406 | Encompass™ SRS Fibreplast™ System | Qfix | 2021-12-13 |
| 10841962111390 | Encompass™ SRS Fibreplast™ System | Qfix | 2021-12-13 |
| 10841962111277 | Lithotomy AirShuttle™ | Qfix | 2021-09-28 |
| 10841962111260 | BoS™ AirShuttle™ | Qfix | 2021-09-28 |
| 10841962111253 | Portrait™ AirShuttle™ | Qfix | 2021-09-28 |
| 10841962111246 | Slate AirShuttle™ | Qfix | 2021-09-28 |
| 10841962111239 | AirDrive Trolley™ | Qfix | 2021-09-28 |
| 10841962111123 | ZiFix Traverse™ | Qfix | 2021-03-23 |
| 10841962110973 | InfinityLock™ | Qfix | 2020-03-04 |
| 10841962110980 | InfinityLock™ | Qfix | 2020-03-04 |
| 10841962110966 | Alta™ | Qfix | 2020-03-04 |
| 10841962110775 | SRS MR Adapter | Qfix | 2020-03-04 |
| 10841962110928 | Encompass™ SRS Fibreplast™ Anterior Mask | Qfix | 2018-12-10 |
| 10841962110768 | SRS Adapter | Qfix | 2018-10-09 |
| 10841962110713 | Symphony™ | Qfix | 2018-04-18 |
| 10841962110706 | Symphony™ | Qfix | 2018-04-18 |
| 10841962110508 | ZiFix™ | Qfix | 2017-07-17 |
| 10841962110447 | Symphony™ BoS™ | Qfix | 2017-03-16 |
| 10841962109557 | Symphony™ Portrait™ | Qfix | 2016-12-22 |
| 10841962109540 | Symphony™ | Qfix | 2016-12-22 |
| 10841962109496 | Encompass™ | Qfix | 2016-09-14 |
| 10841962109533 | Symphony™ | Qfix | 2016-09-14 |
| 10841962109526 | Encompass™ SRS Fibreplast™ System | Qfix | 2016-09-14 |
| 10841962109519 | Encompass™ SRS Fibreplast™ System | Qfix | 2016-09-14 |
| 10841962109502 | Encompass™ | Qfix | 2016-09-14 |