Cleared Traditional

K160518 - LEONI ORION System
(FDA 510(k) Clearance)

K160518 · Leoni Cia Cable System · Radiology

Jul 2016

Decision

141d

Days

Class 2

Risk

K160518 is an FDA 510(k) clearance for the LEONI ORION System. This device is classified as a Couch, Radiation Therapy, Powered (Class II — Special Controls, product code JAI).

Submitted by Leoni Cia Cable System (Chartres, FR). The FDA issued a Cleared decision on July 14, 2016, 141 days after receiving the submission on February 24, 2016.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5770.

Submission Details

510(k) Number	K160518 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2016
Decision Date	July 14, 2016
Days to Decision	141 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF