510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160518Substantially Equivalent

LEONI ORION System

Leoni Cia Cable System, Chartres, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160518 is the FDA 510(k) clearance record for LEONI ORION System, a class II device, cleared for Leoni Cia Cable System on under FDA product code JAI (Couch, Radiation Therapy, Powered). FDA records list one 510(k) clearance for Leoni Cia Cable System. As of , FDA records show 2 recalls naming K160518.

Clearance record

Decision date
Received
(141 days to decision)
Product code
JAI Couch, Radiation Therapy, Powered
Regulation
21 CFR 892.5770
Device class
Class II
Review panel
Radiology
Applicant
Leoni Cia Cable System 5 Ave. Victor Hugo, Chartres, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAI

Trailing 12 months

FDA records hold no clearances under product code JAI in the trailing twelve months.

FDA records show no clearances under product code JAI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JAI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260