RaySearch Laboratories AB (PUBL) FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
RayStation (2024A SP3)510(k)Dec 22, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 22, 2025
RayCare (2024A SP1)510(k)Apr 17, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 17, 2025
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3510(k)Apr 4, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 4, 2025
RayStation 12A510(k)Mar 29, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 29, 2023
RayStation 11B510(k)Apr 15, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 15, 2022
RayStation 11.0510(k)Sep 8, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 8, 2021
RayStation 10.1510(k)Jun 29, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 29, 2021