510(k) · Cleared
ClearedGuideshot Option, Scenaria Whole-Body X-Ray CT System
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 May 3, 2012 as substantially equivalent to K091103 (Hitachi Medical Systems America, Inc., 2009) after a 171-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- May 3, 2012
- Review
- 171 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K944131 (1995). 11 ancestors in all, the oldest K920950 (1992). No later device cites it as a predicate yet.
- Root · 8 generations backK944131 Anatom 2000Analogic Corp. · 1995
- 7 generations backK964890 Anatom 2000Analogic Corp. · 1997
- 6 generations backK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
- 5 generations backK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
- 4 generations backK014240 ProntoHitachi Medical Systems America, Inc. · 2002
- 3 generations backK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
- 2 generations backK071806 Eclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. · 2007 · Recalled
- 1 generation backK091103 Guideshot Option for CXR4 and Eclos CT SystemsHitachi Medical Systems America, Inc. · 2009
- This deviceK113341 Guideshot Option, Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| −7 | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| −6 | K982631 | Philips Tomoscan CS | Philips Medical Systems, Inc. | 1998 | — |
| −5 | K991278 | Philips Tomoscan AV-NT | Philips Medical Systems North America, Inc. | 1999 | — |
| −4 | K014240 | Pronto | Hitachi Medical Systems America, Inc. | 2002 | — |
| −3 | K040902 | Hitachi Presto | Hitachi Medical Systems America, Inc. | 2004 | 4 |
| −2 | K071806 | Eclos Computed Tomography X-Ray System | Hitachi Medical Systems America, Inc. | 2007 | 1 |
| −1 | K091103 | Guideshot Option for CXR4 and Eclos CT Systems | Hitachi Medical Systems America, Inc. | 2009 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K091103 | Guideshot Option for CXR4 and Eclos CT SystemsSummary page 2…nt with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the ECLOS Computed Tomography X-ray System with guideShot Option (K091 103). ©201 1 Hitachi Medical Systems America, Inc. guideShot Option, SCIENARIA Vk/hole-body X-ray CT System PageS3 of 5 ===… | 2009 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 3 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. 2012, 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 SCENARIA Whole-body X-ray CT System with guideShot Option is a x-ray imaging device that produce cross-sectional images of the body at different angles. The system reconstructs, processes, displays, and stores 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/K113341 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113341: Guideshot Option, Scenaria Whole-Body X-Ray CT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113341
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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