510(k) K060870
- Device
- AVANZA
- Applicant
- MDS NORDION
- 510(k) number
- K060870
- Product code
- JAI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-05-15
- Date received
- 2006-03-30
- Regulation
- 892.5770
- Classification name
- Couch, Radiation Therapy, Powered
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROSS KACHANIWSKY
- Address
- 447 March Rd. Ottawa CA k2k 1x8 k2k 1x8
FDA Registration Numbers#
- 3006894636
- 1932738
- 9710332
- 3015232217
- 3006946288
- 2247992
- 2436865
- 3012834372
Source Documents#
Other 510(k) Records For Product Code JAI #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases