RaySearch Laboratories AB (PUBL)

FDA Regulatory Profile

RaySearch Laboratories AB (PUBL) appears in FDA public data with 0 recalls, 15 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 22, 2025.

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252109RayStation (2024A SP3)December 22, 2025
K242992RayCare (2024A SP1)April 17, 2025
K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024April 4, 2025
K222312RayStation 12AMarch 29, 2023
K220141RayStation 11BApril 15, 2022
K211867RayStation 11.0September 8, 2021
K210645RayStation 10.1June 29, 2021
K200569RayStationSeptember 24, 2020
K200487RayCare 3.1June 10, 2020
K191384RayCare 2.3July 8, 2019
K190387RayStationJune 19, 2019
K180379RayStation 7April 25, 2018
K171536RayStationJune 27, 2017
K170355RayStation 6March 2, 2017
K160093RayStationApril 8, 2016