Medical Device Manufacturer · SE , Stockholm

RaySearch Laboratories AB (PUBL) - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 2016

Recent clearances: RayStation (2024A SP3), RayCare (2024A SP1), RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - RaySearch Laboratories AB (PUBL) Radiology ✕

15 devices

1-12 of 15

Cleared Dec 22, 2025

RayStation (2024A SP3)

Radiology · 168d

Cleared Apr 17, 2025

RayCare (2024A SP1)

Radiology · 203d

Cleared Apr 04, 2025

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation...

Radiology · 420d

Cleared Mar 29, 2023

Radiology · 240d

Cleared Apr 15, 2022

Radiology · 87d

Cleared Sep 08, 2021

RayStation 11.0

Radiology · 84d

Cleared Jun 29, 2021

RayStation 10.1

Radiology · 118d

Cleared Sep 24, 2020

Radiology · 204d

Cleared Jun 10, 2020

Radiology · 104d

Cleared Jul 08, 2019

Radiology · 46d

Cleared Jun 19, 2019

Radiology · 120d

Cleared Apr 25, 2018

Radiology · 72d