510(k) · Cleared
ClearedCURA 778
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fmi Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 5, 2020 as substantially equivalent to K160743 (Philips Medical Systems (Cleveland), Inc., 2016) and 1 other predicate after a 167-day review. Its family tree reaches back 9 generations to 1998.
- Decided
- Mar 5, 2020
- Review
- 167 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K982349 (1998). 23 ancestors in all, the oldest K930090 (1993). No later device cites it as a predicate yet.
- Root · 9 generations backK982349 Somatom Plus 4WITH Volume Zoom CT ScannersSiemens Medical Solutions USA, Inc. · 1998
- 5 generations between
- 3 generations backK143401 SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- 2 generations backK151752 SOMATOM Emotion 6/16Siemens Medical Solutions USA, Inc. · 2015
- 1 generation backK173076 CURA 16; ScintCare CT16Fmi Medical Systems, Inc. · 2018
- This deviceK192590 CURA 778Fmi Medical Systems, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK982349 Somatom Plus 4WITH Volume Zoom CT ScannersSiemens Medical Solutions USA, Inc. · 1998
- 8 generations backK013522 Somatom P30 CT SystemsSiemens Medical Systems, Inc. · 2001 · Recalled
- 7 generations backK040665 Somatom Sensation 64 and Sensation CardiacSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK081022 Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- 5 generations backK103127 Somatom Definition asSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 4 generations backK130901 Somatom Definition as OpenSiemens Medical Systems, Inc. · 2014
- 3 generations backK143401 SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- 2 generations backK151752 SOMATOM Emotion 6/16Siemens Medical Solutions USA, Inc. · 2015
- 1 generation backK173076 CURA 16; ScintCare CT16Fmi Medical Systems, Inc. · 2018
- This deviceK192590 CURA 778Fmi Medical Systems, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K982349 | Somatom Plus 4WITH Volume Zoom CT Scanners | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −8 | K013522 | Somatom P30 CT Systems | Siemens Medical Systems, Inc. | 2001 | 9 |
| −7 | K040665 | Somatom Sensation 64 and Sensation Cardiac | Siemens Medical Solutions USA, Inc. | 2004 | 5 |
| −6 | K081022 | Somatom Definition, Model as/as+ | Siemens Medical Solutions USA, Inc. | 2008 | 3 |
| −5 | K103127 | Somatom Definition as | Siemens Medical Solutions USA, Inc. | 2011 | 6 |
| −4 | K130901 | Somatom Definition as Open | Siemens Medical Systems, Inc. | 2014 | — |
| −3 | K143401 | SOMATOM Definition Edge | Siemens Medical Solutions USA, Inc. | 2015 | 3 |
| −2 | K151752 | SOMATOM Emotion 6/16 | Siemens Medical Solutions USA, Inc. | 2015 | — |
| −1 | K173076 | CURA 16; ScintCare CT16 | Fmi Medical Systems, Inc. | 2018 | — |
| 0 (this device) | K192590 | CURA 778 | Fmi Medical Systems, Inc. | 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 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K160743 | Philips Ingenuity CTSummary page 4…umber: 21 CFR 892.1750 Device Class: 2 Predicate Device: Predicate Device: Philips Ingenuity CT Predicate 510(k): K160743 Regulation: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Class:… | 2016 |
| * | K173076 | CURA 16; ScintCare CT16Summary page 7…nc. is citing substantial equivalence of the CURA 778 system to the 510(k), K160743, predicate device Philips Ingenuity CT. Second substantial equivalence to the 510(k), K173076, predicate device CURA 16. Substantial Equivalence Statement: FMI Medical Systems Inc. is citing substantial equivalence of the… | 2018 |
| † | K131299 | Anythink Pacs Workstation | 2013 |
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 22 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 12 of the 23 ancestors have a recall of any class.
- 2 other devices also cite its predicate K160743.
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?
The CURA 778 is a Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes.
The system may include signal analysis and display equipment, patient and equipment supports, components and accessories.
The CURA 778 scanner is a whole body scanner, with cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192590 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192590: CURA 778.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192590
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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