Cleared Traditional

RayStation 7

K180379 · RaySearch Laboratories AB (PUBL) · Radiology
Apr 2018
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K180379 is an FDA 510(k) clearance for the RayStation 7, 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 25, 2018, 72 days after receiving the submission on February 12, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K180379 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2018
Decision Date April 25, 2018
Days to Decision 72 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