510(k) · Cleared
Recalled · Class II · 2022Supria True64 Whole-Body X-Ray CT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Healthcare Americas · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 1, 2019 as substantially equivalent to K171738 (Hitachi Healthcare Americas Corporation, 2017) after a 67-day review. Its family tree reaches back 9 generations to 2003. It has been recalled 2 times.
- Decided
- Feb 1, 2019
- Review
- 67 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 9 generations to K031469 (2003). No later device cites it as a predicate yet.
- Root · 9 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
- 5 generations between
- 3 generations backK161748 SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016
- 2 generations backK163528 HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017
- 1 generation backK171738 Supria True64Hitachi Healthcare Americas Corporation · 2017
- This deviceK183291 Supria True64 Whole-Body X-Ray CT SystemHitachi Healthcare Americas · 2019
Show all 9 generations
- Root · 9 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
- 8 generations backK033418 TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003 · Recalled
- 7 generations backK051833 TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT…Toshiba America Medical Systems, In.C · 2005
- 6 generations backK080211 Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C · 2008 · Recalled
- 5 generations backK101888 Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011 · Recalled
- 4 generations backK123509 Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013
- 3 generations backK161748 SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016
- 2 generations backK163528 HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017
- 1 generation backK171738 Supria True64Hitachi Healthcare Americas Corporation · 2017
- This deviceK183291 Supria True64 Whole-Body X-Ray CT SystemHitachi Healthcare Americas · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K031469 | Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 | Toshiba America Medical Systems, In.C | 2003 | 1 |
| −8 | K033418 | TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners | Toshiba America Medical Systems, In.C | 2003 | 2 |
| −7 | K051833 | TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner | Toshiba America Medical Systems, In.C | 2005 | — |
| −6 | K080211 | Model TSX-101A/H/I Aquilion 32/64 SP CT System | Toshiba America Medical Systems, In.C | 2008 | 8 |
| −5 | K101888 | Scenaria Whole-Body X-Ray CT System | Hitachi Medical Systems America, Inc. | 2011 | 3 |
| −4 | K123509 | Scenaria Phase 2 Whole-Body X-Ray CT System | Hitachi Medical Systems America, Inc. | 2013 | — |
| −3 | K161748 | SUPRIA w/guideShot Option | Hitachi Medical Systems America, Inc. | 2016 | — |
| −2 | K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3 | Hitachi Medical Systems America, Inc. | 2017 | — |
| −1 | K171738 | Supria True64 | Hitachi Healthcare Americas Corporation | 2017 | — |
| 0 (this device) | K183291 | Supria True64 Whole-Body X-Ray CT System | Hitachi Healthcare Americas | 2019 | — |
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 |
|---|---|---|---|
| * | K171738 | Supria True64Summary page 4…II Panel Radiology Predicate Device Name Predicate Device(s): Supria True64 Whole-body X-ray CT System (K171738) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Pr… | 2017 |
| † | K101888 | Scenaria Whole-Body X-Ray CT System | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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-1749-2022 | 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… |
| Jul 12, 2022 | Class II | Z-1750-2022 | 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 16 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K171738.
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. 2019, 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 Supria True64 System is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes. The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume…
Read the full statement (115 words)
The Supria True64 System is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.
The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering. Volume datasets acquired by the Supria 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/K183291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183291: Supria True64 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/K183291
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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