Premica CT Contrast Media Delivery System

by Nycomed Amersham Imaging

510(k) K983314

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K983314↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK983314	Date19 Feb 1999Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K983314
FDA Product Code: IZQ

Device Class: Class II
Regulation: 21 CFR Part 870.1650
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Premica CT Contrast Media Delivery System is an automatic injector designed to deliver contrast media during computed tomography (CT) imaging. It provides controlled, timed injection of contrast agents to enhance vascular and tissue visualization in CT scans.

The system is classified as a Class II medical device and received FDA 510(k) clearance (K983314) as a substantially equivalent injector. It is not intended for use in coronary arteriography or for patients under 16 years of age. The device is identified by product code IZQ and is marketed by Nycomed Amersham Imaging.