LEONI ORION System

FDA 510(k) K160518 · Leoni Cia Cable System

Substantially Equivalent

510(k) numberK160518

Submission

Device name
LEONI ORION System
Applicant
Leoni Cia Cable System
Chartres, FR
Received
February 24, 2016
Decision date
July 14, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAI – Couch, Radiation Therapy, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5770
Specialty
Radiology

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Questions and answers

When was LEONI ORION System cleared by the FDA?

LEONI ORION System (K160518) received a 510(k) decision of Substantially Equivalent on July 14, 2016, 141 days after the submission was received.

What is the product code of K160518?

The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.