510(k) Report

510(k) · Cleared

Cleared

CT Expres Iii Contrast Media Delivery System

K062265510(k) TraditionalCleared Dec 26, 2006144-day reviewClass II21 CFR 870.1650

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Swiss Medical Care S.A. · IZQ Injector, Contrast Medium, Automatic

Cleared on Dec 26, 2006 as substantially equivalent to K983314 (Nycomed Amersham Imaging, 1999) after a 144-day review. Its family tree reaches back 2 generations to 1995. 10 later devices descend from it.

Decided
Dec 26, 2006
Review
144 days
Class
Class II
Product code
IZQ
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K934086 (1995). 10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2024: 3 descendants cleared2017: 1 descendant cleared2020: 1 descendant cleared2025: 3 descendants cleared2021: 1 descendant clearedK934086 · Medrad Envision CT Injector and Qwik Fit Syringe · Medrad, Inc. · 1995K983314 · Premica CT Contrast Media Delivery System · Nycomed Amersham Imaging · 19991995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K983314 · Premica CT Contrast Media Delivery System · Nycomed Amersham Imaging · 1999K934086 · Medrad Envision CT Injector and Qwik Fit Syringe · Medrad, Inc. · 19950+5
  1. Root · 2 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
  2. 1 generation backK983314 Premica CT Contrast Media Delivery SystemNycomed Amersham Imaging · 1999
  3. This deviceK062265 CT Expres Iii Contrast Media Delivery SystemSwiss Medical Care S.A. · 2006
  4. Descendant · cites it directly · 9 of its ownK151048 CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B…Bracco Injeneering · 2016
  5. Descendant · 2 generations on · 6 of its ownK171392 ulrichINJECT CT motionUlrich GmbH & Co. KG · 2017
  6. Descendant · 3 generations on · 5 of its ownK192872 ulrichINJECT CT MotionUlrich GmbH & Co. KG · 2020
  7. Descendant · 4 generations on · 2 of its ownK233737 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD…Ulrich GmbH & Co. KG · 2024
  8. Descendant · 2 generations on · 1 of its ownK241849 MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD…Imaxeon Pty, Ltd. · 2024

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2016: 12017: 12020: 12021: 12024: 32025: 3
2016high 3 (2024) · low 0 (2018)2026

Most influential descendants

Showing 5 of 10 · See all
  • K151048CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP…Bracco Injeneering · 2016 · cites it directly9descendants
  • K171392ulrichINJECT CT motionUlrich GmbH & Co. KG · 2017 · 2 generations on6descendants
  • K192872ulrichINJECT CT MotionUlrich GmbH & Co. KG · 2020 · 3 generations on5descendants
  • K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…Ulrich GmbH & Co. KG · 2024 · 4 generations on2descendants
  • K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…Imaxeon Pty, Ltd. · 2024 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K934086Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc.1995—
−1K983314Premica CT Contrast Media Delivery SystemNycomed Amersham Imaging1999—
0 (this device)K062265CT Expres Iii Contrast Media Delivery SystemSwiss Medical Care S.A.2006—
+1K151048CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III…Bracco Injeneering2016—
+2K171392ulrichINJECT CT motionUlrich GmbH & Co. KG2017—
+3K192872ulrichINJECT CT MotionUlrich GmbH & Co. KG2020—
+4K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150)…Ulrich GmbH & Co. KG2024—
+2K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo…Imaxeon Pty, Ltd.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
202010
202110
202430
202530
FIG. 1 — Lineage of K062265, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IZQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IZQ device

  1. #1 K241850 ulricheasyINJECT Max 2M (XD 10140)…score 12.7 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K983314Premica CT Contrast Media Delivery System
Summary page 1
…medium, automatic (21 CFR 870.1650, Product Code IZQ) 3. PREDICATE DEVICEIS Premica~-CT Contrast Media Delivery System - K983314 4. DEVICE DESCRIPTION The CT Expr6s 11ITM Contrast Media Delivery System (CMDS) is a programmable, software dr…
Nycomed Amersham Imaging1999—

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151048CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP…Bracco Injeneering20169

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K151048 (Bracco Injeneering, 2016) has gone furthest, with 9 descendants of its own.

How does its category compare?

All IZQ devices

IZQ Injector, Contrast Medium, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IZQ

3in 2025

2007: 32010: 12016: 22017: 12020: 12021: 12024: 32025: 32026 (partial year): 1
2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZQ

119in 2025

2007: 168 days median2024: 131 days median2025: 119 days median
2007high 168 (2007) · low 119 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IZQ

2in 2011

2008: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IZQ

21in 2025

2007: 142008: 722009: 482010: 422011: 412012: 232013: 232014: 142015: 52016: 72017: 32018: 82019: 92020: 132021: 142022: 242023: 162024: 232025: 21
2007high 72 (2008) · low 3 (2017)2025

MAUDE reports naming product code IZQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073168014
20080—172
20090—048
20101—042
20110—241
20120—023
20130—023
20140—014
20150—05
20162—07
20171—03
20180—08
20190—09
20201—013
20211—014
20220—024
20230—016
20243131023
20253119021
20261—0—

What is it indicated for?

The CT Expres III™ Contrast Media Delivery System (CMDS) is indicated for controlled automatic administration, on the venous side, of contrast media (CM) to human subjects while undergoing examination by means of a computed tomography (CT) scanner.

The system consists of the CT Expres III™ Instrument, the Bottle Spike, the Day Set III, the Patient Set, accessories and detachable parts.

This device is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated.

This device is only to be operated by and under quasi-continuous supervision of qualified medical staff in an appropriate licensed health care facility.

Indications for use as stated in the FDA summary.

Recent decisions in IZQ

The IZQ category page

  • K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc. · 2026
  • K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG · 2025
  • K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG · 2025
  • K252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo…Imaxeon Pty, Ltd. · 2025
  • K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo…Imaxeon Pty, Ltd. · 2024

https://510kreport.com/device/K062265 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062265: CT Expres Iii Contrast Media Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062265

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026