510(k) · Cleared
Recalled · Class II · 2019SCENARIA Phase 3 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 Oct 30, 2015 as substantially equivalent to K123509 (Hitachi Medical Systems America, Inc., 2013) after a 235-day review. Its family tree reaches back 6 generations to 2003. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 30, 2015
- Review
- 235 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K031469 (2003). 8 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
- 5 generations backK033418 TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003 · Recalled
- 4 generations backK051833 TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT…Toshiba America Medical Systems, In.C · 2005
- 3 generations backK080211 Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C · 2008 · Recalled
- 2 generations backK101888 Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011 · Recalled
- 1 generation backK123509 Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013
- This deviceK150595 SCENARIA Phase 3 Whole-body X-ray CT SystemHitachi Medical Systems America, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK190841 SCENARIA ViewHitachi Healthcare Americas · 2019
- Descendant · 2 generations on · 6 of its ownK200498 SCENARIA ViewHitachi Healthcare Americas · 2020
- Descendant · 3 generations on · 5 of its ownK213829 SCENARIA ViewFujifilm Healthcare Corporation · 2022 · Recalled
- Descendant · 4 generations on · 4 of its ownK231574 Scenaria View 4.2FUJIFILM Healthcare Americas Corporation · 2023
- Descendant · 5 generations on · 2 of its ownK250370 SCENARIA View Phase 5.0Fujifilm Corporation · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K190841SCENARIA ViewHitachi Healthcare Americas · 2019 · cites it directly7descendants
- K200498SCENARIA ViewHitachi Healthcare Americas · 2020 · 2 generations on6descendants
- K213829SCENARIA ViewFujifilm Healthcare Corporation · 2022 · 3 generations on5descendants
- K231574Scenaria View 4.2FUJIFILM Healthcare Americas Corporation · 2023 · 4 generations on4descendants
- K250370SCENARIA View Phase 5.0Fujifilm Corporation · 2025 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K031469 | Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 | Toshiba America Medical Systems, In.C | 2003 | 1 |
| −5 | K033418 | TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners | Toshiba America Medical Systems, In.C | 2003 | 2 |
| −4 | K051833 | TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner | Toshiba America Medical Systems, In.C | 2005 | — |
| −3 | K080211 | Model TSX-101A/H/I Aquilion 32/64 SP CT System | Toshiba America Medical Systems, In.C | 2008 | 8 |
| −2 | K101888 | Scenaria Whole-Body X-Ray CT System | Hitachi Medical Systems America, Inc. | 2011 | 3 |
| −1 | K123509 | Scenaria Phase 2 Whole-Body X-Ray CT System | Hitachi Medical Systems America, Inc. | 2013 | — |
| 0 (this device) | K150595 | SCENARIA Phase 3 Whole-body X-ray CT System | Hitachi Medical Systems America, Inc. | 2015 | — |
| +1 | K190841 | SCENARIA View | Hitachi Healthcare Americas | 2019 | — |
| +2 | K200498 | SCENARIA View | Hitachi Healthcare Americas | 2020 | — |
| +3 | K213829 | SCENARIA View | Fujifilm Healthcare Corporation | 2022 | 1 |
| +4 | K231574 | Scenaria View 4.2 | FUJIFILM Healthcare Americas Corporation | 2023 | — |
| +5 | K250370 | SCENARIA View Phase 5.0 | Fujifilm Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K123509 | Scenaria Phase 2 Whole-Body X-Ray CT SystemSummary page 5…adiology Trade/Proprietary Name: SCENARIA Phase 3 Whole-body X-ray CT System Predicate Device(s): SCENARIA Phase 2 Whole-body X-ray CT System (K123509) Device Intended Use The SCENARIA Phase 3 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomograp… | 2013 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190841 | SCENARIA View | 2019 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2019 | Class II | Z-0271-2020 | Nonconforming Material/Component | There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system. |
| Jun 29, 2018 | Class II | Z-2839-2018 | Nonconforming Material/Component | The firm received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the control was released and contacted the CT gantry. The problem could not be… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K190841 (Hitachi Healthcare Americas, 2019) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K123509.
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. 2015, 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 Phase 3 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the SCENARIA Phase 3 can be post processed by the SCENARIA Phase 3 to provide additional information. Post processing capabilities included in the SCENARIA Phase 3 software include CT angiography…
Read the full statement (126 words)
The SCENARIA Phase 3 system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes.
The volume datasets acquired by the SCENARIA Phase 3 can be post processed by the SCENARIA Phase 3 to provide additional information. Post processing capabilities included in the SCENARIA Phase 3 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the SCENARIA Phase 3 can be transferred to external devices via a DICOM standard interface.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150595: SCENARIA Phase 3 Whole-body X-ray CT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150595
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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