510(k) · Cleared
Recalled · Class II · 2019Scenaria 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 Apr 8, 2011 as substantially equivalent to K080211 (Toshiba America Medical Systems, In.C, 2008) after a 275-day review. Its family tree reaches back 4 generations to 2003. 15 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 8, 2011
- Review
- 275 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K031469 (2003). 15 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
- 3 generations backK033418 TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003 · Recalled
- 2 generations backK051833 TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT…Toshiba America Medical Systems, In.C · 2005
- 1 generation backK080211 Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C · 2008 · Recalled
- This deviceK101888 Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011
- Descendant · cites it directly · 14 of its ownK123509 Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013
- Descendant · 2 generations on · 11 of its ownK161748 SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016
- Descendant · 3 generations on · 10 of its ownK163528 HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017
- Descendant · 4 generations on · 9 of its ownK171738 Supria True64Hitachi Healthcare Americas Corporation · 2017
- Descendant · 2 generations on · 8 of its ownK150595 SCENARIA Phase 3 Whole-body X-ray CT SystemHitachi Medical Systems America, Inc. · 2015 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K123509Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013 · cites it directly14descendants
- K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016 · 2 generations on11descendants
- K163528HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017 · 3 generations on10descendants
- K171738Supria True64Hitachi Healthcare Americas Corporation · 2017 · 4 generations on9descendants
- K150595SCENARIA Phase 3 Whole-body X-ray CT SystemHitachi Medical Systems America, Inc. · 2015 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K031469 | Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 | Toshiba America Medical Systems, In.C | 2003 | 1 |
| −3 | K033418 | TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners | Toshiba America Medical Systems, In.C | 2003 | 2 |
| −2 | K051833 | TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner | Toshiba America Medical Systems, In.C | 2005 | — |
| −1 | K080211 | Model TSX-101A/H/I Aquilion 32/64 SP CT System | Toshiba America Medical Systems, In.C | 2008 | 8 |
| 0 (this device) | K101888 | Scenaria Whole-Body X-Ray CT System | Hitachi Medical Systems America, Inc. | 2011 | — |
| +1 | K123509 | Scenaria Phase 2 Whole-Body X-Ray CT System | Hitachi Medical Systems America, Inc. | 2013 | — |
| +2 | K161748 | SUPRIA w/guideShot Option | Hitachi Medical Systems America, Inc. | 2016 | — |
| +3 | K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3 | Hitachi Medical Systems America, Inc. | 2017 | — |
| +4 | K171738 | Supria True64 | Hitachi Healthcare Americas Corporation | 2017 | — |
| +2 | K150595 | SCENARIA Phase 3 Whole-body X-ray CT System | Hitachi Medical Systems America, Inc. | 2015 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K080211 | Model TSX-101A/H/I Aquilion 32/64 SP CT SystemSummary page 2…892.1750 Regulatory Class Class 11 Predicate Device(s): TOSHIBA AQUILION 64 Slice System (K08021 1) Reason for Submission New Device Device Intended Use The SCENARIA system is indicated to acquire axial… | 2008 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123509 | Scenaria Phase 2 Whole-Body X-Ray CT System | 2013 | 14 |
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 30, 2015 | Class II | Z-2392-2016 | Component design/selection | The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient. |
| May 4, 2012 | Class II | Z-2037-2012 | Software design | Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued for processing, if a queue is suspended… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K123509 (Hitachi Medical Systems America, Inc., 2013) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K080211.
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. 2011, 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 Scenadia system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes.
The volume datasets acquired by the Scenadia can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the Scenaria can be transferred to external devices via a DICOM standard interface.
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/K101888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101888: Scenaria 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/K101888
Report an extraction error
Are you the manufacturer?
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