Cleared Traditional

RayStation 12A

K222312 · RaySearch Laboratories AB (PUBL) · Radiology
Mar 2023
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K222312 is an FDA 510(k) clearance for the RayStation 12A, 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 March 29, 2023, 240 days after receiving the submission on August 1, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K222312 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2022
Decision Date March 29, 2023
Days to Decision 240 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