RayCare 3.1— 510(k) K200487
Substantially EquivalentRaySearch Laboratories AB (PUBL)
FDA 510(k) clearance K200487 for RayCare 3.1, Substantially Equivalent on 2020-06-10. Applicant: RaySearch Laboratories AB (PUBL). Device class: 2.
Clearance details
- Applicant
- RaySearch Laboratories AB (PUBL)
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Recent devices under product code MUJ
view allMore clearances from RaySearch Laboratories AB (PUBL)
view allRecalls naming K200487
K-number listed on FDA's recall record- Z-0206-2024 — 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 Product name (build number): (1)RayCare 5B SP1 (5.1.1.60246); (2)RayCare 5B SP3 (5.1.3.60023); (3) RayCare 6A (6.0.0.60553)
- Z-2464-2023 — 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 treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0
- Z-2138-2021 — 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; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297; RayStation 10.0 (10.0.0.1154) 07350002010303; RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365; RayStation 10.1 (10.1.0.613) 07350002010310; RayStation 11.0 (11.0.0.951) 07350002010389;
- Z-1281-2021 — RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
- Z-2899-2020 — 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200487.
Data sourced from openFDA. This site is unofficial and independent of the FDA.