Medical Device Manufacturer · SE , Stockholm

RaySearch Laboratories AB (PUBL)

15 submissions · 15 cleared · Since 2016
15
Total
15
Cleared
0
Denied

RaySearch Laboratories AB (PUBL) — FDA 510(k) Submissions

RaySearch Laboratories AB (PUBL) has submitted 15 FDA 510(k) premarket notifications since 2016, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Planning, Radiation Therapy Treatment . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
RayStation (2024A SP3)
K252109 · MUJ System, Planning,... · Radiology
Dec 2025 168d
RayCare (2024A SP1)
K242992 · MUJ System, Planning,... · Radiology
Apr 2025 203d
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
K240398 · MUJ System, Planning,... · Radiology
Apr 2025 420d
RayStation 12A
K222312 · MUJ System, Planning,... · Radiology
Mar 2023 240d
RayStation 11B
K220141 · MUJ System, Planning,... · Radiology
Apr 2022 87d
RayStation 11.0
K211867 · MUJ System, Planning,... · Radiology
Sep 2021 84d
RayStation 10.1
K210645 · MUJ System, Planning,... · Radiology
Jun 2021 118d
RayStation
K200569 · MUJ System, Planning,... · Radiology
Sep 2020 204d
RayCare 3.1
K200487 · MUJ System, Planning,... · Radiology
Jun 2020 104d
RayCare 2.3
K191384 · MUJ System, Planning,... · Radiology
Jul 2019 46d
RayStation
K190387 · MUJ System, Planning,... · Radiology
Jun 2019 120d
RayStation 7
K180379 · MUJ System, Planning,... · Radiology
Apr 2018 72d
RayStation
K171536 · MUJ System, Planning,... · Radiology
Jun 2017 33d
RayStation 6
K170355 · MUJ System, Planning,... · Radiology
Mar 2017 24d
RayStation
K160093 · MUJ System, Planning,... · Radiology
Apr 2016 80d
Filters
All15 Radiology 15