510(k) · Cleared
ClearedPremica CT Contrast Media Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nycomed Amersham Imaging · IZQ Injector, Contrast Medium, Automatic
Cleared on Feb 19, 1999 as substantially equivalent to K934086 (Medrad, Inc., 1995) after a 151-day review. Its family tree reaches back 1 generation to 1995. 11 later devices descend from it.
- Decided
- Feb 19, 1999
- Review
- 151 days
- Class
- Class II
- Product code
- IZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934086 (1995). 11 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- This deviceK983314 Premica CT Contrast Media Delivery SystemNycomed Amersham Imaging · 1999
- Descendant · cites it directly · 10 of its ownK062265 CT Expres Iii Contrast Media Delivery SystemSwiss Medical Care S.A. · 2006
- Descendant · 2 generations on · 9 of its ownK151048 CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B…Bracco Injeneering · 2016
- Descendant · 3 generations on · 6 of its ownK171392 ulrichINJECT CT motionUlrich GmbH & Co. KG · 2017
- Descendant · 4 generations on · 5 of its ownK192872 ulrichINJECT CT MotionUlrich GmbH & Co. KG · 2020
- Descendant · 5 generations on · 2 of its ownK233737 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD…Ulrich GmbH & Co. KG · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K062265CT Expres Iii Contrast Media Delivery SystemSwiss Medical Care S.A. · 2006 · cites it directly10descendants
- K151048CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP…Bracco Injeneering · 2016 · 2 generations on9descendants
- K171392ulrichINJECT CT motionUlrich GmbH & Co. KG · 2017 · 3 generations on6descendants
- K192872ulrichINJECT CT MotionUlrich GmbH & Co. KG · 2020 · 4 generations on5descendants
- K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…Ulrich GmbH & Co. KG · 2024 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| 0 (this device) | K983314 | Premica CT Contrast Media Delivery System | Nycomed Amersham Imaging | 1999 | — |
| +1 | K062265 | CT Expres Iii Contrast Media Delivery System | Swiss Medical Care S.A. | 2006 | — |
| +2 | K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III… | Bracco Injeneering | 2016 | — |
| +3 | K171392 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2017 | — |
| +4 | K192872 | ulrichINJECT CT Motion | Ulrich GmbH & Co. KG | 2020 | — |
| +5 | K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150)… | Ulrich GmbH & Co. KG | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
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 K241850 ulricheasyINJECT Max 2M (XD 10140)…score 12.7 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K934086 | Medrad Envision CT Injector and Qwik Fit SyringeSummary page 1…sual Name: Automatic injector for contrast media Classification Name: Injector, contrast medium, automatic 3. PREDICATE DEVICE/S MEDRAD® ENVISION CT™ Injector System - K934086 74 - XT 4, DEVICE DESCRIPTION The Premica™-CT Contrast Media Delivery System consists of the following components: . the conso… | 1995 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062265 | CT Expres Iii Contrast Media Delivery System | 2006 | 10 |
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?
How does its category compare?
All IZQ devicesIZQ Injector, Contrast Medium, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZQ
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZQ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZQ
21in 2025
MAUDE reports naming product code IZQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 168 | 0 | 14 |
| 2008 | 0 | — | 1 | 72 |
| 2009 | 0 | — | 0 | 48 |
| 2010 | 1 | — | 0 | 42 |
| 2011 | 0 | — | 2 | 41 |
| 2012 | 0 | — | 0 | 23 |
| 2013 | 0 | — | 0 | 23 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 1 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 3 | 131 | 0 | 23 |
| 2025 | 3 | 119 | 0 | 21 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Premica™-CT Contrast Media Delivery System is indicated for the controlled automatic administration, on the venous side, of contrast media (CM) for computed tomography scan. The System consists of the Premica™-CT instrument, the Bottle Spike, the Day Set, the Patient Set, and accessories. The System is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated. The Premica™-CT Contrast Media Delivery System is not intended for use with children under 16 years of age.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983314 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983314: Premica CT 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/K983314
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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