Cleared Traditional

K200487 - RayCare 3.1
(FDA 510(k) Clearance)

K200487 · RaySearch Laboratories AB (PUBL) · Radiology
Jun 2020
Decision
104d
Days
Class 2
Risk

K200487 is an FDA 510(k) clearance for the RayCare 3.1, 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 10, 2020, 104 days after receiving the submission on February 27, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K200487 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2020
Decision Date June 10, 2020
Days to Decision 104 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