510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K152361Substantially Equivalent

OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System

Mallinckrodt, Inc., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152361 is the FDA 510(k) clearance record for OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System, a class II device, cleared for Liebel-Flarsheim Company, LLC on under FDA product code IZQ (Injector, Contrast Medium, Automatic). FDA records list 5 510(k) clearances for Mallinckrodt, Inc., from to . As of , FDA records show no recalls naming K152361.

Clearance record

Decision date
Received
(147 days to decision)
Product code
IZQ Injector, Contrast Medium, Automatic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Liebel-Flarsheim Company, LLC 2111 E. Galbraith Rd., Cincinnati OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZQ

Trailing 12 months
3 clearances under product code IZQ in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IZQ, trailing twelve months
MonthClearances
November 20252
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260