510(k) · Cleared
ClearedTrue Enhance DL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Japan Corporation · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 11, 2024 as substantially equivalent to K213938 (Ge Healthcare Japan Corporation, 2022) after a 146-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Apr 11, 2024
- Review
- 146 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K013561 (2001). No later device cites it as a predicate yet.
- Root · 10 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 6 generations between
- 3 generations backK192686 Revolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd. · 2019 · Recalled
- 2 generations backK203169 Revolution AscendGe Healthcare Japan Corporation · 2020 · Recalled
- 1 generation backK213938 Revolution AscendGe Healthcare Japan Corporation · 2022 · Recalled
- This deviceK233698 True Enhance DLGe Healthcare Japan Corporation · 2024
Show all 10 generations
- Root · 10 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 9 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 8 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 7 generations backK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- 6 generations backK082761 GE Lightspeed 7.2 CT Scanner SystemGe Medical Systems, LLC · 2008 · Recalled
- 5 generations backK110227 Optima CT660Ge Medical Systems, LLC · 2011 · Recalled
- 4 generations backK131576 Optima CT660Ge Medical Systems, LLC · 2013 · Recalled
- 3 generations backK192686 Revolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd. · 2019 · Recalled
- 2 generations backK203169 Revolution AscendGe Healthcare Japan Corporation · 2020 · Recalled
- 1 generation backK213938 Revolution AscendGe Healthcare Japan Corporation · 2022 · Recalled
- This deviceK233698 True Enhance DLGe Healthcare Japan Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −9 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −8 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −7 | K061817 | Lightspeed 7.1 CT Scanner System | Ge Medical Systems, LLC | 2006 | 1 |
| −6 | K082761 | GE Lightspeed 7.2 CT Scanner System | Ge Medical Systems, LLC | 2008 | 3 |
| −5 | K110227 | Optima CT660 | Ge Medical Systems, LLC | 2011 | 5 |
| −4 | K131576 | Optima CT660 | Ge Medical Systems, LLC | 2013 | 8 |
| −3 | K192686 | Revolution Maxima, Revolution Ace | Ge Hangwei Medical Systems Co., Ltd. | 2019 | 5 |
| −2 | K203169 | Revolution Ascend | Ge Healthcare Japan Corporation | 2020 | 1 |
| −1 | K213938 | Revolution Ascend | Ge Healthcare Japan Corporation | 2022 | 2 |
| 0 (this device) | K233698 | True Enhance DL | Ge Healthcare Japan Corporation | 2024 | — |
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 |
|---|---|---|---|
| * | K213938 | Revolution AscendSummary page 4…roduct Code: Predicate Device Information Device Name: Revolution Ascend Manufacturer: GE Medical Systems, LLC 510(k) Number: K213938 cleared on February 4, 2022 Regulation Number/ 21 CFR 892.1750 Computed tomography x-ray system / JAK 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 23 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 10 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K213938.
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?
True Enhance DL is a deep learning-based image processing method trained to estimate monochromatic, 50 keV GSI images. The algorithm is intended to improve the contrast of 120 kVp, single energy images of the body.
This device is intended to provide non-quantitative, adjunct information and should not be interpreted without the original 120 kVp image.
True Enhance DL may be used for patients of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233698: True Enhance DL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233698
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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