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

Total

Cleared

Denied

RaySearch Laboratories AB (PUBL) has 15 FDA 510(k) cleared radiology devices. Based in Stockholm, SE.

Latest FDA clearance: Dec 2025. Active since 2016.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

RaySearch Laboratories AB (PUBL) is one of 59 FDA 510(k) medical device manufacturers from Sweden in the dataset, ranked by real submission volume.

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

15 devices

1-15 of 15

Cleared Dec 22, 2025

RayStation (2024A SP3)

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

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

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

Filters