Cleared Traditional

RayCare 2.3

K191384 · RaySearch Laboratories AB (PUBL) · Radiology
Jul 2019
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K191384 is an FDA 510(k) clearance for the RayCare 2.3, 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 July 8, 2019, 46 days after receiving the submission on May 23, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K191384 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2019
Decision Date July 08, 2019
Days to Decision 46 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