Cleared Traditional

K190387 - RayStation
(FDA 510(k) Clearance)

K190387 · RaySearch Laboratories AB (PUBL) · Radiology
Jun 2019
Decision
120d
Days
Class 2
Risk

K190387 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 June 19, 2019, 120 days after receiving the submission on February 19, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K190387 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2019
Decision Date June 19, 2019
Days to Decision 120 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