510(k) · Cleared
Recalled · Class II · 2022SCENARIA View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Healthcare Corporation · JAK System, X-Ray, Tomography, Computed
Cleared on May 23, 2022 as substantially equivalent to K200498 (Hitachi Healthcare Americas, 2020) after a 166-day review. Its family tree reaches back 11 generations to 2003. 5 later devices descend from it. It has been recalled once.
- Decided
- May 23, 2022
- Review
- 166 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K031469 (2003). 12 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
- 7 generations between
- 3 generations backK171738 Supria True64Hitachi Healthcare Americas Corporation · 2017
- 2 generations backK190841 SCENARIA ViewHitachi Healthcare Americas · 2019
- 1 generation backK200498 SCENARIA ViewHitachi Healthcare Americas · 2020
- This deviceK213829 SCENARIA ViewFujifilm Healthcare Corporation · 2022
- Descendant · cites it directly · 4 of its ownK231574 Scenaria View 4.2FUJIFILM Healthcare Americas Corporation · 2023
- Descendant · 2 generations on · 2 of its ownK250370 SCENARIA View Phase 5.0Fujifilm Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK261229 SCENARIA View Phase 6.0Fujifilm Corporation · 2026
- Descendant · 3 generations on · 0 of its ownK253836 FCT iStream Phase 2Fujifilm Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK233583 FCT iSTREAM Phase 1FUJIFILM Healthcare Americas Corporation · 2024
Show all 11 generations
- Root · 11 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
- 10 generations backK033418 TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003 · Recalled
- 9 generations backK051833 TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT…Toshiba America Medical Systems, In.C · 2005
- 8 generations backK080211 Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C · 2008 · Recalled
- 7 generations backK101888 Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011 · Recalled
- 6 generations backK123509 Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013
- 5 generations backK161748 SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016
- 4 generations backK163528 HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017
- 3 generations backK171738 Supria True64Hitachi Healthcare Americas Corporation · 2017
- 2 generations backK190841 SCENARIA ViewHitachi Healthcare Americas · 2019
- 1 generation backK200498 SCENARIA ViewHitachi Healthcare Americas · 2020
- This deviceK213829 SCENARIA ViewFujifilm Healthcare Corporation · 2022
Most influential descendants
Showing 5 of 5 · See all- K231574Scenaria View 4.2FUJIFILM Healthcare Americas Corporation · 2023 · cites it directly4descendants
- K250370SCENARIA View Phase 5.0Fujifilm Corporation · 2025 · 2 generations on2descendants
- K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026 · 3 generations on0descendants
- K253836FCT iStream Phase 2Fujifilm Corporation · 2026 · 3 generations on0descendants
- K233583FCT iSTREAM Phase 1FUJIFILM Healthcare Americas Corporation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K031469 | Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 | Toshiba America Medical Systems, In.C | 2003 | 1 |
| −10 | K033418 | TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners | Toshiba America Medical Systems, In.C | 2003 | 2 |
| −9 | K051833 | TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner | Toshiba America Medical Systems, In.C | 2005 | — |
| −8 | K080211 | Model TSX-101A/H/I Aquilion 32/64 SP CT System | Toshiba America Medical Systems, In.C | 2008 | 8 |
| −7 | K101888 | Scenaria Whole-Body X-Ray CT System | Hitachi Medical Systems America, Inc. | 2011 | 3 |
| −6 | K123509 | Scenaria Phase 2 Whole-Body X-Ray CT System | Hitachi Medical Systems America, Inc. | 2013 | — |
| −5 | K161748 | SUPRIA w/guideShot Option | Hitachi Medical Systems America, Inc. | 2016 | — |
| −4 | K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3 | Hitachi Medical Systems America, Inc. | 2017 | — |
| −3 | K171738 | Supria True64 | Hitachi Healthcare Americas Corporation | 2017 | — |
| −2 | K190841 | SCENARIA View | Hitachi Healthcare Americas | 2019 | — |
| −1 | K200498 | SCENARIA View | Hitachi Healthcare Americas | 2020 | — |
| 0 (this device) | K213829 | SCENARIA View | Fujifilm Healthcare Corporation | 2022 | — |
| +1 | K231574 | Scenaria View 4.2 | FUJIFILM Healthcare Americas Corporation | 2023 | — |
| +2 | K250370 | SCENARIA View Phase 5.0 | Fujifilm Corporation | 2025 | — |
| +3 | K261229 | SCENARIA View Phase 6.0 | Fujifilm Corporation | 2026 | — |
| +3 | K253836 | FCT iStream Phase 2 | Fujifilm Corporation | 2026 | — |
| +2 | K233583 | FCT iSTREAM Phase 1 | FUJIFILM Healthcare Americas Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K200498 | SCENARIA ViewSummary page 4…uted Class II Panel Radiology Predicate Device Name Predicate Device(s): SCENARIA View (K200498) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Pr… | 2020 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231574 | Scenaria View 4.2 | 2023 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2022 | Class II | Z-1748-2022 | Under Investigation by firm | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K231574 (FUJIFILM Healthcare Americas Corporation, 2023) has gone furthest, with 4 descendants of its own.
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. 2022, 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 View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle guidance. Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include, multi-planar…
Read the full statement (147 words)
The SCENARIA View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle guidance.
Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include, multi-planar reconstruction (MPR), and volume rendering.
Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface.
The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or FUJIFILM Healthcare Americas Corporation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213829: SCENARIA View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213829
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