510(k) K200487 ยท MUJ System, Planning, Radiation Therapy Treatment
RayCare 3.1
| Applicant | RaySearch Laboratories AB (PUBL), Stockholm, SE |
| Decision | Substantially Equivalent, Jun 10, 2020 |
| Received | Feb 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200487
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2023 | RAYSEARCH LABORATORIES AB RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Open, Classified |
MUJ | None listed |
| Aug 25, 2023 | RAYSEARCH LABORATORIES AB RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and trea Open, Classified |
MUJ | None listed |
| Jun 8, 2021 | RAYSEARCH LABORATORIES AB RayStation (Radiation Treatment Planning System) :
RayStation 9A, 9B, 9B SP1, 10A, 10A
SP1, 10B and 11A, in combination with RayCare
Model Numbers/ UDI:
RayStation 9.0 (9.0.0.113) 07350002010174;
Ra Terminated |
MUJ | None listed |
| Mar 3, 2021 | RAYSEARCH LABORATORIES AB RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care. Open, Classified |
MUJ | None listed |
| Jul 29, 2020 | RAYSEARCH LABORATORIES AB RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Open, Classified |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.