510(k) · Cleared
ClearedAV Cardiac CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 5, 2026 as substantially equivalent to K150665 (Philips Medical Systems Nethrlands BV, 2015) after a 44-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Mar 5, 2026
- Review
- 44 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K930090 (1993). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
- 5 generations between
- 3 generations backK131773 Brilliance IctPhilips Healthcare (Cleveland) · 2013
- 2 generations backK133674 Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 2014 · Recalled
- 1 generation backK150665 Philips Spectral CT ApplicationsPhilips Medical Systems Nethrlands BV · 2015 · Recalled
- This deviceK260169 AV Cardiac CTPhilips Medical Systems Nederland B.V. · 2026
Show all 9 generations
- Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
- 8 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 7 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 6 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 4 generations backK060937 Brilliance VolumePhilips Medical Systems (Cleveland), Inc. · 2006 · Recalled
- 3 generations backK131773 Brilliance IctPhilips Healthcare (Cleveland) · 2013
- 2 generations backK133674 Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 2014 · Recalled
- 1 generation backK150665 Philips Spectral CT ApplicationsPhilips Medical Systems Nethrlands BV · 2015 · Recalled
- This deviceK260169 AV Cardiac CTPhilips Medical Systems Nederland B.V. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −8 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −7 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −6 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −5 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −4 | K060937 | Brilliance Volume | Philips Medical Systems (Cleveland), Inc. | 2006 | 61 |
| −3 | K131773 | Brilliance Ict | Philips Healthcare (Cleveland) | 2013 | — |
| −2 | K133674 | Philips Iqon Spectral CT | Philips Healthcare (Cleveland) | 2014 | 6 |
| −1 | K150665 | Philips Spectral CT Applications | Philips Medical Systems Nethrlands BV | 2015 | 1 |
| 0 (this device) | K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K150665 | Philips Spectral CT ApplicationsSummary page 5…y Product Code QIH Classification 21 CFR 892.1750, 21 CFR 892.2050 Primary Predicate Device Philips Medical Systems’ Spectral CT Applications (K150665) Reference Device GE Medical Systems’ CardIQ Suite (K213725) Device Description AV Cardiac CT is a standa… | 2015 |
| † | K213725 | CardIQ Suite | 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 33 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 7 of the 14 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. 2026, 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 AV Cardiac CT applications are intended to assist the user in viewing, processing, analysis of CT datasets and in preparation of cardiac interventions.
The CT Coronary Analysis application is indicated to assist radiologists, cardiologists, and 3D technologists in the analysis of coronary artery anatomy for patients with suspected or diagnosed cardiac disease including coronary artery disease.
The CT Functional Analysis application is indicated to assist radiologists, cardiologists, and 3D technologists in the analysis of heart anatomy and function, for patients with suspected or diagnosed cardiac disease.
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/K260169 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260169: AV Cardiac CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260169
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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