510(k) Report

510(k) · Cleared

Cleared

Scenaria Phase 2 Whole-Body X-Ray CT System

K123509510(k) TraditionalCleared Mar 29, 2013136-day reviewClass II21 CFR 892.1750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hitachi Medical Systems America, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Mar 29, 2013 as substantially equivalent to K101888 (Hitachi Medical Systems America, Inc., 2011) after a 136-day review. Its family tree reaches back 5 generations to 2003. 14 later devices descend from it.

Decided
Mar 29, 2013
Review
136 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K031469 (2003). 14 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2015: 2 descendants cleared2019: 2 descendants cleared2017: 2 descendants cleared2020: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant cleared2026: 2 descendants clearedK031469 · Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 · Toshiba America Medical Systems, In.C · 2003 · recalledK033418 · TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners · Toshiba America Medical Systems, In.C · 2003 · recalledK051833 · TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner · Toshiba America Medical Systems, In.C · 2005K080211 · Model TSX-101A/H/I Aquilion 32/64 SP CT System · Toshiba America Medical Systems, In.C · 2008 · recalledK101888 · Scenaria Whole-Body X-Ray CT System · Hitachi Medical Systems America, Inc. · 2011 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant6 generations forward: 2 descendants7 generations forward: 2 descendants K101888 · Scenaria Whole-Body X-Ray CT System · Hitachi Medical Systems America, Inc. · 2011 · recalledK080211 · Model TSX-101A/H/I Aquilion 32/64 SP CT System · Toshiba America Medical Systems, In.C · 2008 · recalledK051833 · TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner · Toshiba America Medical Systems, In.C · 2005K033418 · TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners · Toshiba America Medical Systems, In.C · 2003 · recalledK031469 · Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 · Toshiba America Medical Systems, In.C · 2003 · recalled−50+5
  1. Root · 5 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
  2. 4 generations backK033418 TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003 · Recalled
  3. 3 generations backK051833 TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT…Toshiba America Medical Systems, In.C · 2005
  4. 2 generations backK080211 Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C · 2008 · Recalled
  5. 1 generation backK101888 Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011 · Recalled
  6. This deviceK123509 Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013
  7. Descendant · cites it directly · 11 of its ownK161748 SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016
  8. Descendant · 2 generations on · 10 of its ownK163528 HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017
  9. Descendant · 3 generations on · 9 of its ownK171738 Supria True64Hitachi Healthcare Americas Corporation · 2017
  10. Descendant · cites it directly · 8 of its ownK150595 SCENARIA Phase 3 Whole-body X-ray CT SystemHitachi Medical Systems America, Inc. · 2015 · Recalled
  11. Descendant · 2 generations on · 7 of its ownK190841 SCENARIA ViewHitachi Healthcare Americas · 2019

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2015: 22016: 12017: 22019: 22020: 12022: 12023: 12024: 12025: 12026: 2
2015high 2 (2015) · low 0 (2018)2026

Most influential descendants

Showing 5 of 14 · See all
  • K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016 · cites it directly11descendants
  • K163528HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017 · 2 generations on10descendants
  • K171738Supria True64Hitachi Healthcare Americas Corporation · 2017 · 3 generations on9descendants
  • K150595SCENARIA Phase 3 Whole-body X-ray CT SystemHitachi Medical Systems America, Inc. · 2015 · cites it directly8descendants
  • K190841SCENARIA ViewHitachi Healthcare Americas · 2019 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K031469Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C20031
−4K033418TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C20032
−3K051833TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT ScannerToshiba America Medical Systems, In.C2005—
−2K080211Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C20088
−1K101888Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.20113
0 (this device)K123509Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.2013—
+1K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.2016—
+2K163528HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc.2017—
+3K171738Supria True64Hitachi Healthcare Americas Corporation2017—
+1K150595SCENARIA Phase 3 Whole-body X-ray CT SystemHitachi Medical Systems America, Inc.20152
+2K190841SCENARIA ViewHitachi Healthcare Americas2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201610
201720
201920
202010
202210
202310
202410
202510
202620
FIG. 1 — Lineage of K123509, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K101888Scenaria Whole-Body X-Ray CT System
Summary page 1
…Regulatory Class Class It ___ Predicate Device(s): ------ SCEN-ARIA Whole-body X-ray CT System (K101888) Reason for Submission New Technology Device Intended Use The SCENARIA Phase 2 system is indicated for…
Hitachi Medical Systems America, Inc.20113

What descends from it? (14)

See all 14

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.201611
K150595SCENARIA Phase 3 Whole-body X-ray CT SystemHitachi Medical Systems America, Inc.20158
K150565Supria Whole-body X-ray CT SystemHitachi Medical Systems America, Inc.20150

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 10 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
  • 4 of the 5 ancestors have a recall of any class.
  • Of its descendants, K161748 (Hitachi Medical Systems America, Inc., 2016) has gone furthest, with 11 descendants of its own.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · JAK

27in 2025

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

What is it indicated for?

The SCENARIA Phase 2 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 2 can be post processed by the SCENARIA Phase 2 to provide additional information. Post processing capabilities included in the SCENARIA Phase 2 software include CT angiography…

Read the full statement (126 words)

The SCENARIA Phase 2 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 2 can be post processed by the SCENARIA Phase 2 to provide additional information. Post processing capabilities included in the SCENARIA Phase 2 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.

Volume datasets acquired by the SCENARIA Phase 2 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 as stated in the FDA summary.

More from Hitachi Medical Systems America, Inc.

100 FDA decisions under this applicant name. See the company

  • K163528HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017
  • K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc. · 2016
  • K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016
  • K160152Trillium Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc. · 2016
  • K153547ECHELON Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc. · 20162 recalls

Recent decisions in JAK

The JAK category page

  • K260391AVIEW Aorta MetricsCoreline Soft Co., Ltd. · 2026
  • K261225CAS-One IRCascination AG · 2026
  • K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
  • K253836FCT iStream Phase 2Fujifilm Corporation · 2026

https://510kreport.com/device/K123509 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123509: Scenaria Phase 2 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/K123509

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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