Cleared Traditional

K983314 - PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM

K983314 is an FDA 510(k) clearance for PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM, manufactured by Nycomed Amersham Imaging. The device is a Class 2 Cardiovascular device with product code IZQ cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K983314 · Nycomed Amersham Imaging · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
151d
Days
Class 2
Risk

K983314 is an FDA 510(k) clearance for the PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM. Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Nycomed Amersham Imaging (North Attleboro, US). The FDA issued a Cleared decision on February 19, 1999 after a review of 151 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Nycomed Amersham Imaging devices

FDA 510(k) Submission Details - K983314

510(k) Number K983314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1998
Decision Date February 19, 1999
Days to Decision 151 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 125d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZQ Device Classification - Class 2, Special Controls

Product Code IZQ Injector, Contrast Medium, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - IZQ Injector, Contrast Medium, Automatic

All 16
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K983314.
EMPOWERMR INJECTOR SYSTEM, MODEL 9730
K062449 · E-Z-Em, Inc. · Apr 2007
MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY
K063090 · Medrad, Inc. · Mar 2007
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
K031571 · E-Z-Em, Inc. · Jun 2003
ACIST INJECTOR SYSTEM, MODEL CL100 H
K984058 · Acist Medical Systems · Feb 1999
MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N
K760641 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1976
MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N
K760643 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1976