510(k) · Cleared
ClearedGE Xtreme Injector Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 17, 2008 as substantially equivalent to K061976 (Toshiba America Medical Systems, In.C, 2006) and 1 other predicate after a 14-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Oct 17, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K934086 (1995). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 4 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
- 3 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
- 2 generations backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
- 1 generation backK061976 Ckis-004A Injector Synchronization OptionToshiba America Medical Systems, In.C · 2006
- This deviceK082960 GE Xtreme Injector OptionGe Medical Systems, LLC · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −4 | K993728 | Medrad Envision CT Injector System | Medrad, Inc. | 1999 | — |
| −3 | K023183 | Medrad Stellant CT Injector System | Medrad, Inc. | 2003 | 6 |
| −2 | K033881 | Medrad Stellant CT Injector System with Imaging System Interface Module | Medrad, Inc. | 2004 | 1 |
| −1 | K061976 | Ckis-004A Injector Synchronization Option | Toshiba America Medical Systems, In.C | 2006 | — |
| 0 (this device) | 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 |
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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K061976 | Ckis-004A Injector Synchronization OptionSummary page 1…f a comparable type and substantially equivalent to currently marketed Toshiba Injector Synchronization Option (K061976), and Siemens CARE CONTRAST CT (K043087) and complies with the same or… | 2006 |
| * | K043087 | Somatom Care Contrast CTSummary page 1…uivalent to currently marketed Toshiba Injector Synchronization Option (K061976), and Siemens CARE CONTRAST CT (K043087) and complies with the same or equivalent standards and have similar intended… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 11 ancestors have a recall of any class.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The GE Xtream Injector Option is designed to facilitate contrast-enhanced Computed Tomography (CT) by providing a method for connection and communication to the CT system with a compatible injector. When used, it allows the user to synchronize the start of the CT scan and the injector by pressing one single start button at the CT scanner. The GE Xtream Injector Option is based on the protocol contained in the CIA425 standard, and allows approved…
Read the full statement (122 words)
The GE Xtream Injector Option is designed to facilitate contrast-enhanced Computed Tomography (CT) by providing a method for connection and communication to the CT system with a compatible injector. When used, it allows the user to synchronize the start of the CT scan and the injector by pressing one single start button at the CT scanner. The GE Xtream Injector Option is based on the protocol contained in the CIA425 standard, and allows approved injectors to operate with certain GE Healthcare CT scanners that have the modified software and hardware interface required for the CIA425 communication protocol. This device is only the communication protocol and bus interface needed to communicate with a 510(k) cleared Injector that is compatible with the CIA425 standard.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082960: GE Xtreme Injector Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082960
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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