510(k) · Cleared
ClearedFCT iSTREAM Phase 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FUJIFILM Healthcare Americas Corporation · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 26, 2024 as substantially equivalent to K231574 (FUJIFILM Healthcare Americas Corporation, 2023) after a 171-day review. Its family tree reaches back 13 generations to 2003.
- Decided
- Apr 26, 2024
- Review
- 171 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K031469 (2003). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
- 9 generations between
- 3 generations backK200498 SCENARIA ViewHitachi Healthcare Americas · 2020
- 2 generations backK213829 SCENARIA ViewFujifilm Healthcare Corporation · 2022 · Recalled
- 1 generation backK231574 Scenaria View 4.2FUJIFILM Healthcare Americas Corporation · 2023
- This deviceK233583 FCT iSTREAM Phase 1FUJIFILM Healthcare Americas Corporation · 2024
Show all 13 generations
- Root · 13 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
- 12 generations backK033418 TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003 · Recalled
- 11 generations backK051833 TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT…Toshiba America Medical Systems, In.C · 2005
- 10 generations backK080211 Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C · 2008 · Recalled
- 9 generations backK101888 Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011 · Recalled
- 8 generations backK123509 Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013
- 7 generations backK161748 SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016
- 6 generations backK163528 HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017
- 5 generations backK171738 Supria True64Hitachi Healthcare Americas Corporation · 2017
- 4 generations backK190841 SCENARIA ViewHitachi Healthcare Americas · 2019
- 3 generations backK200498 SCENARIA ViewHitachi Healthcare Americas · 2020
- 2 generations backK213829 SCENARIA ViewFujifilm Healthcare Corporation · 2022 · Recalled
- 1 generation backK231574 Scenaria View 4.2FUJIFILM Healthcare Americas Corporation · 2023
- This deviceK233583 FCT iSTREAM Phase 1FUJIFILM Healthcare Americas Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K031469 | Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 | Toshiba America Medical Systems, In.C | 2003 | 1 |
| −12 | K033418 | TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners | Toshiba America Medical Systems, In.C | 2003 | 2 |
| −11 | K051833 | TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner | Toshiba America Medical Systems, In.C | 2005 | — |
| −10 | K080211 | Model TSX-101A/H/I Aquilion 32/64 SP CT System | Toshiba America Medical Systems, In.C | 2008 | 8 |
| −9 | K101888 | Scenaria Whole-Body X-Ray CT System | Hitachi Medical Systems America, Inc. | 2011 | 3 |
| −8 | K123509 | Scenaria Phase 2 Whole-Body X-Ray CT System | Hitachi Medical Systems America, Inc. | 2013 | — |
| −7 | K161748 | SUPRIA w/guideShot Option | Hitachi Medical Systems America, Inc. | 2016 | — |
| −6 | K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3 | Hitachi Medical Systems America, Inc. | 2017 | — |
| −5 | K171738 | Supria True64 | Hitachi Healthcare Americas Corporation | 2017 | — |
| −4 | K190841 | SCENARIA View | Hitachi Healthcare Americas | 2019 | — |
| −3 | K200498 | SCENARIA View | Hitachi Healthcare Americas | 2020 | — |
| −2 | K213829 | SCENARIA View | Fujifilm Healthcare Corporation | 2022 | 1 |
| −1 | K231574 | Scenaria View 4.2 | FUJIFILM Healthcare Americas Corporation | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K231574 | Scenaria View 4.2Summary page 4…X-Ray, Tomography, Computed Class II Panel Radiology Predicate Device Name Predicate Device(s): SCENARIA View 4.2 (K231574) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Product Code… | 2023 |
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 21 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K231574.
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. 2024, 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 FCT iStream 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 FCT iStream system can also be used for interventional needle guidance. Volume datasets acquired by an FCT iStream system can be post-processed in the FCT iStream system to provide additional information. Post-processing capabilities of the FCT iStream software include multi-planar…
Read the full statement (146 words)
The FCT iStream 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 FCT iStream system can also be used for interventional needle guidance. Volume datasets acquired by an FCT iStream system can be post-processed in the FCT iStream system to provide additional information. Post-processing capabilities of the FCT iStream software include multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by an FCT iStream system can be transferred to external devices via a DICOM standard interface.
The Low Dose CT Lung Cancer Screening Option for the FCT iStream 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 Corporation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233583 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233583: FCT iSTREAM Phase 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233583
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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