JAI — Couch, Radiation Therapy, Powered Class II
FDA product code JAI covers "Couch, Radiation Therapy, Powered", a Class II medical device regulated under 21 CFR 892.5770. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JAI
- Device Class
- Class II
- Regulation Number
- 892.5770
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231612 | leo cancer care | Eve Patient Positioner System | May 7, 2024 |
| K182683 | chinan biomedical technology | Z-Robot Patient Positioning System | June 27, 2019 |
| K170502 | forte automation systems | Patient Positioning System | April 13, 2017 |
| K160518 | leoni cia cable system | LEONI ORION System | July 14, 2016 |
| K132084 | med-tec, inc. d/b/a civco medical solutions | PROTURA COUCH SOFTWARE | September 26, 2013 |
| K122413 | forte automation systems | PATIENT POSITIONING SYSTEM | September 13, 2012 |
| K122201 | med-tec, inc. d/b/a civco medical solutions | PROTURA COUCH SOFTWARE | August 30, 2012 |
| K120520 | brainlab | EXACTRAC ROBOTICS NOVALIS ROBOTICS | June 29, 2012 |
| K120916 | wfr/aquaplast | QFIX RADIOTHERAPY CHAIR | June 20, 2012 |
| K072898 | medical intelligence medizintechnik | HEXAPOD EVO RT COUCH TOP | October 25, 2007 |
| K071870 | medical intelligence medizintechnik | HEXAPOD RT COUCH TOP | July 8, 2007 |
| K062639 | medical intelligence medizintechnik-gmbh-an elekta | MODIFICATION TO HEXAPOD RT COUCH TOP | September 21, 2006 |
| K060870 | mds nordion | AVANZA | May 15, 2006 |
| K060671 | wfr/aquaplast | KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS | May 4, 2006 |
| K050422 | siemens medical solutions usa | 550 TXT TREATMENT TABLE | March 18, 2005 |
| K042146 | accuray incorporated | ROBOCOUCH PATIENT SUPPORT SYSTEM | September 17, 2004 |
| K041448 | medical intelligence medizintechnik | HEXAPOD RT COUCHTOP | June 16, 2004 |
| K033316 | brainlab | TABLE TILT DEVICE | May 14, 2004 |
| K034054 | med-tec | PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 | February 20, 2004 |
| K031866 | med-tec | MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC | August 14, 2003 |