510(k) · Cleared
ClearedHealthFLD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nano-X AI, Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 8, 2024 as substantially equivalent to K213944 (Nanoxai, Ltd., 2022) after a 135-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Feb 8, 2024
- Review
- 135 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K954678 (1996). 89 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet.
- Root · 12 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations between
- 3 generations backK123584 Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc. · 2013
- 2 generations backK193267 Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc. · 2020
- 1 generation backK213944 HealthOSTNanoxai, Ltd. · 2022
- This deviceK233080 HealthFLDNano-X AI, Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 11 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 10 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 9 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 8 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 7 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 6 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 5 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 4 generations backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- 3 generations backK123584 Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc. · 2013
- 2 generations backK193267 Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc. · 2020
- 1 generation backK213944 HealthOSTNanoxai, Ltd. · 2022
- This deviceK233080 HealthFLDNano-X AI, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −11 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −10 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −9 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −8 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −7 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −6 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| −5 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −4 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| −3 | K123584 | Syngo, CT Bone Reading | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −2 | K193267 | Al-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | 2020 | — |
| −1 | K213944 | HealthOST | Nanoxai, Ltd. | 2022 | — |
| 0 (this device) | K233080 | HealthFLD | Nano-X AI, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K213944 | HealthOSTSummary page 4…uivalent to the following Predicate Device: Proprietary Name Predicate Device: Nano-X AI HealthOST device Premarket Notification K213944 Classification Name Computed tomography x-ray system. Regulation Number 21 CFR §892.1750 Product Code… | 2022 |
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 28 years and passes through 10 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 89 ancestors have a recall of any class.
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 HealthFLD device is an image processing software that provides quantitative and qualitative analysis of the liver from CT images to support clinicians in the evaluation and assessment of Fatty Liver. The HealthFLD software provides measurements of liver attenuation (mean HU in a region of interest). HealthFLD is indicated for use in non-contrast and contrast CT scans, with any clinical indication, for patients aged 18 up to 75. CTs must include a significant part of the liver. The HealthFLD device is not intended to provide a diagnosis or risk assessment of fatty liver disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233080 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233080: HealthFLD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233080
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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