Cleared Traditional

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

K240398 · RaySearch Laboratories AB (PUBL) · Radiology
Apr 2025
Decision
420d
Days
Class 2
Risk

About This 510(k) Submission

K240398 is an FDA 510(k) clearance for the RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3, a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by RaySearch Laboratories AB (PUBL) (Stockholm, SE). The FDA issued a Cleared decision on April 4, 2025, 420 days after receiving the submission on February 9, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K240398 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2024
Decision Date April 04, 2025
Days to Decision 420 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUJ — System, Planning, Radiation Therapy Treatment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050