Cleared Traditional

RayStation 11.0

K211867 · RaySearch Laboratories AB (PUBL) · Radiology
Sep 2021
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K211867 is an FDA 510(k) clearance for the RayStation 11.0, 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 September 8, 2021, 84 days after receiving the submission on June 16, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K211867 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2021
Decision Date September 08, 2021
Days to Decision 84 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