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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 7, 2024 | K231612 | Eve Patient Positioner System Leo Cancer Care | JAI |
| Jun 27, 2019 | K182683 | Z-Robot Patient Positioning System Chinan Biomedical Technology, Inc., TW | JAI |
| Apr 13, 2017 | K170502 | Patient Positioning System Forte Automation Systems, Inc. | JAI |
| Jul 14, 2016 | K160518 | LEONI ORION System Leoni Cia Cable System, FR | JAI |
| Sep 26, 2013 | K132084 | PROTURA COUCH SOFTWARE Med-Tec, Inc. D/B/A Civco Medical Solutions | JAI |
| Sep 13, 2012 | K122413 | PATIENT POSITIONING SYSTEM Forte Automation Systems, Inc. | JAI |
| Aug 30, 2012 | K122201 | PROTURA COUCH SOFTWARE Med-Tec, Inc. D/B/A Civco Medical Solutions | JAI |
| Jun 29, 2012 | K120520 | EXACTRAC ROBOTICS NOVALIS ROBOTICS Brainlab AG, DE | JAI |
| Jun 20, 2012 | K120916 | QFIX RADIOTHERAPY CHAIR Wfr/Aquaplast Corp. | JAI |
| Oct 25, 2007 | K072898 | HEXAPOD EVO RT COUCH TOP Medical Intelligence Medizintechnik GmbH, DE | JAI |
| Jul 8, 2007 | K071870 | HEXAPOD RT COUCH TOP Medical Intelligence Medizintechnik GmbH, DE | JAI |
| Sep 21, 2006 | K062639 | MODIFICATION TO HEXAPOD RT COUCH TOP Medical Intelligence Medizintechnik-GmbH-An Elekta, DE | JAI |
| May 15, 2006 | K060870 | AVANZA Mds Nordion, CA | JAI |
| May 4, 2006 | K060671 | KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS Wfr/Aquaplast Corp. | JAI |
| Mar 18, 2005 | K050422 | 550 TXT TREATMENT TABLE Siemens Medical Solutions USA, Inc. | JAI |
| Sep 17, 2004 | K042146 | ROBOCOUCH PATIENT SUPPORT SYSTEM Accuray Incorporated | JAI |
| Jun 16, 2004 | K041448 | HEXAPOD RT COUCHTOP Medical Intelligence Medizintechnik GmbH, DE | JAI |
| May 14, 2004 | K033316 | TABLE TILT DEVICE Brainlab AG, DE | JAI |
| Feb 20, 2004 | K034054 | PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 Med-Tec,Inc. | JAI |
| Aug 14, 2003 | K031866 | MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC Med-Tec,Inc. | JAI |
| Dec 7, 2001 | K013036 | NOMOS MOTORIZED CRANE II Nomos Corp. | JAI |
| Jan 10, 2000 | K993522 | AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT Aktina Medical Physics Corp. | JAI |
| Jan 15, 1999 | K983678 | ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE Elekta Instruments, Inc. | JAI |
| Sep 29, 1998 | K982446 | DYNAMIC SHIELDING RADIATION TABLE American Biophysics, Inc. | JAI |
| Feb 11, 1997 | K964740 | THE NOMOS MINICRANE Nomos Corp. | JAI |
| Feb 9, 1995 | K941927 | THE NOMOS CRANE Nomos Corp. | JAI |
| Jul 22, 1991 | K910648 | THERAPY CHAIR SYSTEM Radiation Technology, Inc., AU | JAI |
| Jul 22, 1991 | K910002 | GENESYS AND THE ROI The Complete Systems Corp. Genesys | JAI |
| May 3, 1991 | K910971 | Z XT RADIATION THERAPY TREATMENT TABLE Siemens Medical Laboratories, Inc. | JAI |
| Jan 30, 1986 | K855063 | UNIVERSAL PATIENT CHAIR UNI 2000X Siemens Medical Solutions USA, Inc. | JAI |
| Mar 5, 1984 | K834201 | TCT-1 TREATMENT COUCH Therados, Inc. | JAI |
| Mar 22, 1983 | K837152 | THERAC 25 LINEAR ACCELERATOR Atomic Energy of Canada, CA | JAI |
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