510(k) · Cleared
ClearedDeep Recon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Healthcare Co., Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Jul 6, 2020 as substantially equivalent to K172135 (Shanghai United Imaging Healthcare Co., Ltd., 2018) and 1 other predicate after a 245-day review. Its family tree reaches back 9 generations to 2001.
- Decided
- Jul 6, 2020
- Review
- 245 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K013561 (2001). 25 ancestors in all, the oldest K930090 (1993). No later device cites it as a predicate yet.
- Root · 9 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 5 generations between
- 3 generations backK133705 Revolution CTGe Medical Systems, LLC · 2014 · Recalled
- 2 generations backK163213 Revolution CTGe Medical Systems, LLC · 2016 · Recalled
- 1 generation backK183202 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019
- This deviceK193073 Deep ReconShanghai United Imaging Healthcare Co., Ltd. · 2020
Show all 9 generations
- Root · 9 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 8 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 7 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 6 generations backK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- 5 generations backK081105 GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare · 2008 · Recalled
- 4 generations backK120833 Discovery CT750 HDGe Medical Systems, LLC · 2012 · Recalled
- 3 generations backK133705 Revolution CTGe Medical Systems, LLC · 2014 · Recalled
- 2 generations backK163213 Revolution CTGe Medical Systems, LLC · 2016 · Recalled
- 1 generation backK183202 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019
- This deviceK193073 Deep ReconShanghai United Imaging Healthcare Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −8 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −7 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −6 | K061817 | Lightspeed 7.1 CT Scanner System | Ge Medical Systems, LLC | 2006 | 1 |
| −5 | K081105 | GE Lightspeed CT750 HD (Lightspeed 8.0) | GE Healthcare | 2008 | 5 |
| −4 | K120833 | Discovery CT750 HD | Ge Medical Systems, LLC | 2012 | 1 |
| −3 | K133705 | Revolution CT | Ge Medical Systems, LLC | 2014 | 14 |
| −2 | K163213 | Revolution CT | Ge Medical Systems, LLC | 2016 | 16 |
| −1 | K183202 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2019 | — |
| 0 (this device) | K193073 | Deep Recon | Shanghai United Imaging Healthcare Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K172135 | uCT Computed Tomography X-ray SystemSummary page 4…Regulatory Class: II Product Code: JAK Review Panel: Radiology 4. Identification of Predicate Device(s) Primary Predicate Device: 510(k) Number: K172135 Device Name: uCT Computed Tomography X-Ray System Model(s): uCT 760, uCT 780 Regulatory Information Regulati… | 2018 |
| * | K183202 | Deep Learning Image ReconstructionSummary page 4…me: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology Secondary Predicate Device: 510(k) Number: K183202 Device Name: Deep Learning Image Reconstruction Page 1 of 5… | 2019 |
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 19 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 16 of the 25 ancestors have a recall of any class.
- 4 other devices also cite its predicate K172135.
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. 2020, 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?
Deep Recon is a data driven image reconstruction method based on deep learning technology. It is intended to produce
cross-sectional images by computer reconstruction of X-ray transmission data taken at different angles planes, including
Axial, Helical, and Cardiac acquisition.
Deep Recon is designed to generate CT images with lower image noise, and improved low contrast detectability, and it
can reduce the dose required for diagnostic CT imaging.
Deep Recon can be used for head, chest, abdomen, cardiac and vascular CT applications for adults.
Deep Recon is intended to be used with uCT 760 and uCT 780 only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193073: Deep Recon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193073
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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