510(k) K123371 ยท IYE Accelerator, Linear, Medical
ALIGNRT PLUS
| Applicant | Vision RT Limited, London, GB |
| Decision | Substantially Equivalent, Jan 8, 2013 |
| Received | Nov 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123371
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2018 | Vision RT Ltd Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface o Terminated |
IYE | None listed |
| Jul 11, 2016 | Varian Medical Systems, Inc. Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE;
Radiology: The AlignRT Plus system is indicated for use to position
and monitor patients relative Terminated |
IYE | None listed |
| Jul 11, 2016 | Varian Medical Systems, Inc. Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE;
Radiology: The AlignRT Plus system is indicated for use to position
and monitor patients relative to the presc Terminated |
IYE | None listed |
| Jun 30, 2016 | Vision RT Ltd AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam autom Terminated |
IYE | None listed |
| Dec 16, 2014 | Vision Rt Inc AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere i Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.