Cleared Traditional

K241849 - MEDRAD Centargo CT Injection System (FDA 510(k) Clearance)

Also includes:
MEDRAD Centargo Day Set MEDRAD Centargo Patient Line MEDRAD Centargo Replacement Spike MEDRAD ISI2 Module (ISI2)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241849 · Imaxeon Pty, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
131d
Days
Class 2
Risk

K241849 is an FDA 510(k) clearance for the MEDRAD Centargo CT Injection System. Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Imaxeon Pty, Ltd. (Rydalmere, AU). The FDA issued a Cleared decision on November 5, 2024 after a review of 131 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1650 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Imaxeon Pty, Ltd. devices

Submission Details

510(k) Number K241849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2024
Decision Date November 05, 2024
Days to Decision 131 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 128d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 General Hospital devices follow this clearance model.

Regulatory Consultant

Bayer Medical Care, Inc.
Gopal Abbineni

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IZQ Injector, Contrast Medium, Automatic

All 21
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K241849.
ulricheasyINJECT Max 2M (XD 10140)
K252281 · Ulrich GmbH & Co. KG · Nov 2025
ulrichINJECT CT Motion (XD 8000)
K251295 · Ulrich GmbH & Co. KG · Nov 2025
MEDRAD Centargo CT Injection System
K252689 · Imaxeon Pty, Ltd. · Sep 2025
ulricheasyINJECT Max 2M (XD 10140)
K241850 · Ulrich GmbH & Co. KG · Aug 2024
ulricheasyINJECT Max 2M (XD 10140)
K233737 · Ulrich GmbH & Co. KG · Apr 2024
ulrichINJECT CT motion
K210541 · Ulrich GmbH & Co. KG · Aug 2021