510(k) · Cleared
ClearedGuideshot Option for CXR4 and Eclos CT Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 15, 2009 as substantially equivalent to K040902 (Hitachi Medical Systems America, Inc., 2004) and 1 other predicate after a 60-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- Jun 15, 2009
- Review
- 60 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K944131 (1995). 10 ancestors in all, the oldest K920950 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 6 generations backK964890 Anatom 2000Analogic Corp. · 1997
- 5 generations backK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
- 4 generations backK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
- 3 generations backK014240 ProntoHitachi Medical Systems America, Inc. · 2002
- 2 generations backK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
- 1 generation backK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
- This deviceK091103 Guideshot Option for CXR4 and Eclos CT SystemsHitachi Medical Systems America, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK113341 Guideshot Option, Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K113341Guideshot Option, Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −6 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| −5 | K982631 | Philips Tomoscan CS | Philips Medical Systems, Inc. | 1998 | — |
| −4 | K991278 | Philips Tomoscan AV-NT | Philips Medical Systems North America, Inc. | 1999 | — |
| −3 | K014240 | Pronto | Hitachi Medical Systems America, Inc. | 2002 | — |
| −2 | K040902 | Hitachi Presto | Hitachi Medical Systems America, Inc. | 2004 | 4 |
| −1 | K071806 | Eclos Computed Tomography X-Ray System | Hitachi Medical Systems America, Inc. | 2007 | 1 |
| 0 (this device) | K091103 | Guideshot Option for CXR4 and Eclos CT Systems | Hitachi Medical Systems America, Inc. | 2009 | — |
| +1 | K113341 | Guideshot Option, Scenaria Whole-Body X-Ray CT System | Hitachi Medical Systems America, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 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 |
|---|---|---|---|
| * | K040902 | Hitachi PrestoSummary page 1…guideShot PREDICATE DEVICE(S): Hitachi Presto (CXR4) Computed Tomography X-ray System, 510(k) K040902 Hitachi ECLOS Computed Tomography X-ray System,… | 2004 |
| * | K071806 | Eclos Computed Tomography X-Ray SystemSummary page 1…System, 510(k) K040902 Hitachi ECLOS Computed Tomography X-ray System, 510(k) K071806 Device Intended Use The CXR4 and ECLOS Computed Tomography Systems with guideShot Option are x- ray imaging devices that produc… | 2007 |
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 |
|---|---|---|---|
| K113341 | Guideshot Option, Scenaria Whole-Body X-Ray CT System | 2012 | 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 14 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K113341 (Hitachi Medical Systems America, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K040902.
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. 2009, 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 CXR4 Computed Tomography System with guideShot Option are x-ray imaging devices that produce cross-sectional images of the body at different angles. The systems reconstruct, process, display, and store the collected images. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091103: Guideshot Option for CXR4 and Eclos CT Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091103
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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