Company profile

RaySearch Laboratories AB (PUBL)

RaySearch Laboratories AB (PUBL) has 8 AI-enabled medical devices on the FDA list. The first decision was on June 19, 2019 and the most recent on April 4, 2025 (RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3). Its most common review panel is Radiology (8 devices).

8AI devices

2019First decision

2025Latest decision

1Specialties

Per year

201920202021202220232025

RaySearch Laboratories AB (PUBL) AI devices per year: 2019 2, 2020 1, 2021 2, 2022 1, 2023 1, 2025 1

By specialty

Radiology8

Related guides

Top radiology devices

Timeline

April 4, 2025 · 510(k) K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 · Radiology · MUJ
March 29, 2023 · 510(k) K222312RayStation 12A · Radiology · MUJ
April 15, 2022 · 510(k) K220141RayStation 11B · Radiology · MUJ
September 8, 2021 · 510(k) K211867RayStation 11.0 · Radiology · MUJ
June 29, 2021 · 510(k) K210645RayStation 10.1 · Radiology · MUJ
September 24, 2020 · 510(k) K200569RayStation · Radiology · MUJ
July 8, 2019 · 510(k) K191384RayCare 2.3 · Radiology · MUJ
June 19, 2019 · 510(k) K190387RayStation · Radiology · MUJ