Cleared Traditional

K984058 - ACIST INJECTOR SYSTEM, MODEL CL100 H

K984058 is an FDA 510(k) clearance for ACIST INJECTOR SYSTEM, manufactured by Acist Medical Systems. The device is a Class 2 Cardiovascular device with product code IZQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K984058 · Acist Medical Systems · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
90d
Days
Class 2
Risk

K984058 is an FDA 510(k) clearance for the ACIST INJECTOR SYSTEM, MODEL CL100 H. Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Acist Medical Systems (Eden Prairie, US). The FDA issued a Cleared decision on February 11, 1999 after a review of 90 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K984058

510(k) Number K984058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1998
Decision Date February 11, 1999
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 22
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K984058.
CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM
K062265 · Swiss Medical Care S.A. · Dec 2006
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
K031571 · E-Z-Em, Inc. · Jun 2003
PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM
K983314 · Nycomed Amersham Imaging · Feb 1999
KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)
K951005 · Kenex , Ltd. · May 1995
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