Cleared Traditional

RayStation

K200569 · RaySearch Laboratories AB (PUBL) · Radiology
Sep 2020
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K200569 is an FDA 510(k) clearance for the RayStation, 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 24, 2020, 204 days after receiving the submission on March 4, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K200569 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2020
Decision Date September 24, 2020
Days to Decision 204 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