FDA Product Code
FDA Product Code JAI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5770
510(k) Clearances — 32 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231612 | Eve Patient Positioner System | Leo Cancer Care | 2024-05-07 | Traditional | PDF ↗ |
| K182683 | Z-Robot Patient Positioning System | Chinan Biomedical Technology, Inc. | 2019-06-27 | Traditional | PDF ↗ |
| K170502 | Patient Positioning System | Forte Automation Systems, Inc. | 2017-04-13 | Special | PDF ↗ |
| K160518 | LEONI ORION System | Leoni Cia Cable System | 2016-07-14 | Traditional | PDF ↗ |
| K132084 | PROTURA COUCH SOFTWARE | Med-Tec, Inc. D/B/A Civco Medical Solutions | 2013-09-26 | Traditional | PDF ↗ |
| K122413 | PATIENT POSITIONING SYSTEM | Forte Automation Systems, Inc. | 2012-09-13 | Traditional | PDF ↗ |
| K122201 | PROTURA COUCH SOFTWARE | Med-Tec, Inc. D/B/A Civco Medical Solutions | 2012-08-30 | Traditional | PDF ↗ |
| K120520 | EXACTRAC ROBOTICS NOVALIS ROBOTICS | Brainlab AG | 2012-06-29 | Traditional | PDF ↗ |
| K120916 | QFIX RADIOTHERAPY CHAIR | Wfr/Aquaplast Corp. | 2012-06-20 | Traditional | PDF ↗ |
| K072898 | HEXAPOD EVO RT COUCH TOP | Medical Intelligence Medizintechnik GmbH | 2007-10-25 | Special | PDF ↗ |
| K071870 | HEXAPOD RT COUCH TOP | Medical Intelligence Medizintechnik GmbH | 2007-07-08 | Special | PDF ↗ |
| K062639 | MODIFICATION TO HEXAPOD RT COUCH TOP | Medical Intelligence Medizintechnik-GmbH-An Elekta | 2006-09-21 | Special | PDF ↗ |
| K060870 | AVANZA | Mds Nordion | 2006-05-15 | Traditional | PDF ↗ |
| K060671 | KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS | Wfr/Aquaplast Corp. | 2006-05-04 | Traditional | PDF ↗ |
| K050422 | 550 TXT TREATMENT TABLE | Siemens Medical Solutions USA, Inc. | 2005-03-18 | Special | PDF ↗ |
| K042146 | ROBOCOUCH PATIENT SUPPORT SYSTEM | Accuray Incorporated | 2004-09-17 | Traditional | PDF ↗ |
| K041448 | HEXAPOD RT COUCHTOP | Medical Intelligence Medizintechnik GmbH | 2004-06-16 | Traditional | PDF ↗ |
| K033316 | TABLE TILT DEVICE | Brainlab AG | 2004-05-14 | Traditional | PDF ↗ |
| K034054 | PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 | Med-Tec,Inc. | 2004-02-20 | Traditional | PDF ↗ |
| K031866 | MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC | Med-Tec,Inc. | 2003-08-14 | Traditional | PDF ↗ |
| K013036 | NOMOS MOTORIZED CRANE II | Nomos Corp. | 2001-12-07 | Traditional | PDF ↗ |
| K993522 | AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT | Aktina Medical Physics Corp. | 2000-01-10 | Traditional | PDF ↗ |
| K983678 | ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE | Elekta Instruments, Inc. | 1999-01-15 | Traditional | PDF ↗ |
| K982446 | DYNAMIC SHIELDING RADIATION TABLE | American Biophysics, Inc. | 1998-09-29 | Traditional | PDF ↗ |
| K964740 | THE NOMOS MINICRANE | Nomos Corp. | 1997-02-11 | Traditional | PDF ↗ |
| K941927 | THE NOMOS CRANE | Nomos Corp. | 1995-02-09 | Traditional | PDF ↗ |
| K910648 | THERAPY CHAIR SYSTEM | Radiation Technology, Inc. | 1991-07-22 | Traditional | PDF ↗ |
| K910002 | GENESYS AND THE ROI | The Complete Systems Corp. Genesys | 1991-07-22 | Traditional | PDF ↗ |
| K910971 | Z XT RADIATION THERAPY TREATMENT TABLE | Siemens Medical Laboratories, Inc. | 1991-05-03 | Traditional | PDF ↗ |
| K855063 | UNIVERSAL PATIENT CHAIR UNI 2000X | Siemens Medical Solutions USA, Inc. | 1986-01-30 | Traditional | PDF ↗ |
| K834201 | TCT-1 TREATMENT COUCH | Therados, Inc. | 1984-03-05 | Traditional | PDF ↗ |
| K837152 | THERAC 25 LINEAR ACCELERATOR | Atomic Energy of Canada | 1983-03-22 | Traditional | PDF ↗ |
Product code JAI · Class II · Radiology. Data: openFDA.