510(k) · Cleared
ClearedCkis-004A Injector Synchronization Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · DXT Injector And Syringe, Angiographic
Cleared on Sep 27, 2006 as substantially equivalent to K043087 (Siemens Medical Solutions USA, Inc., 2004) and 1 other predicate after a 76-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Sep 27, 2006
- Review
- 76 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K934086 (1995). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 3 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
- 2 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
- 1 generation backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
- This deviceK061976 Ckis-004A Injector Synchronization OptionToshiba America Medical Systems, In.C · 2006
- Descendant · cites it directly · 0 of its ownK082960 GE Xtreme Injector OptionGe Medical Systems, LLC · 2008
Most influential descendants
Showing 1 of 1 · See all- K082960GE Xtreme Injector OptionGe Medical Systems, LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −3 | K993728 | Medrad Envision CT Injector System | Medrad, Inc. | 1999 | — |
| −2 | K023183 | Medrad Stellant CT Injector System | Medrad, Inc. | 2003 | 6 |
| −1 | K033881 | Medrad Stellant CT Injector System with Imaging System Interface Module | Medrad, Inc. | 2004 | 1 |
| 0 (this device) | K061976 | Ckis-004A Injector Synchronization Option | Toshiba America Medical Systems, In.C | 2006 | — |
| +1 | K082960 | GE Xtreme Injector Option | Ge Medical Systems, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 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 DXT? 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 DXT device
- #1 K253048 High Pressure Syringe; Pressure Connecting…score 13.6 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K043087 | Somatom Care Contrast CT Our reading of the summary gave K043807, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Siemens Care Contrast CT”. | 2004 |
| * | K033881 | Medrad Stellant CT Injector System with Imaging System Interface ModuleSummary page 1…X-ray Equipment Standard Predicate Device(s): Siemens Care Contrast CT; k043807 Medrad Stellant CT Injector; k033881 Reason For Submission Modification of cleared device Description of this Device: The CKIS-004A will be added to t… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082960 | GE Xtreme Injector Option | 2008 | 0 |
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 2 companies; a new generation was cleared every 3.1 years on median.
- 6 of the 10 ancestors have a recall of any class.
- Of its descendants, K082960 (Ge Medical Systems, LLC, 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K043087.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXT
138in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXT
10in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXT
97in 2025
MAUDE reports naming product code DXT, 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 | 182 | 4 | 107 |
| 2008 | 2 | — | 3 | 168 |
| 2009 | 6 | 137 | 7 | 188 |
| 2010 | 1 | — | 3 | 124 |
| 2011 | 4 | 69 | 3 | 133 |
| 2012 | 0 | — | 7 | 135 |
| 2013 | 2 | — | 0 | 141 |
| 2014 | 6 | 144 | 0 | 97 |
| 2015 | 7 | 153 | 1 | 135 |
| 2016 | 8 | 172 | 0 | 152 |
| 2017 | 7 | 183 | 0 | 128 |
| 2018 | 9 | 93 | 2 | 129 |
| 2019 | 4 | 96 | 0 | 121 |
| 2020 | 3 | 154 | 1 | 93 |
| 2021 | 1 | — | 1 | 132 |
| 2022 | 0 | — | 0 | 111 |
| 2023 | 1 | — | 2 | 117 |
| 2024 | 4 | 138 | 10 | 118 |
| 2025 | 1 | — | 0 | 97 |
| 2026 | 7 | 264 | 6 | — |
What is it indicated for?
X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy
The CKIS-004A, Injector Synchronization Option is intended to facilitate contrast enhanced CT examinations by interfacing the CT system to a contrast injection system. When employed, the CKIS-004A will allow both the CT scan and the contrast bolus to occur by activation of either the CT or the injector. The communications between the devices is based upon the CiA-425 standard.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061976 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061976: Ckis-004A Injector Synchronization Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061976
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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