Cleared Traditional

RayCare (2024A SP1)

K242992 · RaySearch Laboratories AB (PUBL) · Radiology
Apr 2025
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K242992 is an FDA 510(k) clearance for the RayCare (2024A SP1), 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 17, 2025, 203 days after receiving the submission on September 26, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K242992 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2024
Decision Date April 17, 2025
Days to Decision 203 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