RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3

RaySearch Laboratories AB (PUBL) · K240398 · 2025-04-04

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 is an AI-enabled medical device from RaySearch Laboratories AB (PUBL), listed by FDA (510(k), K240398) with a decision date of 2025-04-04. Review panel: Radiology.

FDA submission numberK240398
Pathway510(k)
CompanyRaySearch Laboratories AB (PUBL)
Review panel (specialty)Radiology
FDA decision date2025-04-04
DecisionSubstantially Equivalent
Product codeMUJ
ClassificationSystem, Planning, Radiation Therapy Treatment
Device class2
Regulation number892.5050
Review time (calendar days)420
Applicant countrySE

Official FDA database record · FDA AI-enabled device list

More devices from RaySearch Laboratories AB (PUBL) · All Radiology AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.