510(k) · Cleared
Recalled · Class II · 2014CT Transcatheter Aortic Valve Implantation (Tavi) Planning Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 13, 2014 as substantially equivalent to K111245 (Philips Medical Systems Nederland B.V., 2011) and 1 other predicate after a 305-day review. Its family tree reaches back 9 generations to 1989. It has been recalled once.
- Decided
- Jun 13, 2014
- Review
- 305 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K890348 (1989). 60 ancestors in all, the oldest K852353 (1985). No later device cites it as a predicate yet.
- Root · 9 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 5 generations between
- 3 generations backK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- 2 generations backK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- 1 generation backK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
- This deviceK132524 CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems · 2014
Show all 9 generations
- Root · 9 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 8 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 7 generations backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
- 6 generations backK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
- 5 generations backK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
- 4 generations backK031836 Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
- 3 generations backK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- 2 generations backK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- 1 generation backK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
- This deviceK132524 CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −8 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −7 | K020055 | Philips Integris Allura 9 with FD Option | Philips Medical Systems | 2002 | 2 |
| −6 | K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips Medical Systems North America Co. | 2002 | 8 |
| −5 | K031333 | Philips Integris Allura Flat Detector Release 1.2 | Philips Medical Systems North America, Inc. | 2003 | 25 |
| −4 | K031836 | Philips Fresco Release 1 | Philips Medical Systems North America Co. | 2003 | — |
| −3 | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| −2 | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
| −1 | K111245 | Heartnavigator Release 1 | Philips Medical Systems Nederland B.V. | 2011 | — |
| 0 (this device) | K132524 | CT Transcatheter Aortic Valve Implantation (Tavi) Planning Application | Philips Medical Systems | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K111245 | Heartnavigator Release 1Summary page 5…result in any new potential hazard. Philips Medical Systems considers CT TAVI Planning Application to be substantially equivalent to the Philips HeartNavigator (KI 111245) and the Vital Images Vitrea CT TAVR Planning (K 133578).… | 2011 |
| * | K122578 | Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) PlanningSummary page 2…te Device k#: KI 11245 2. Predicate Device: Vitrea CT TAVR Planning Manufacturer: Vital Images Predicate Device k#: K 122578 21 CFR 807.92(a) (4): Description of the device that is the subject of this premarket notification: 1. Summary of functions… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2014 | Class II | Z-0473-2015 | Software design | Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (THV) to be implanted . |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 24 of the 60 ancestors have a recall of any class.
- 3 other devices also cite its predicate K111245.
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. 2014, 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 CT TAVI Planning application is intended to be used for patients with aortic valvular disease, severe symptomatic aortic stenosis or tricuspid aortic valve. The intended part of the body for this application is the human heart specifically the ascending aorta, aortic root, coronary ostia and left ventricle in order to assess the aortic valve in pre-operational planning of transcatheter aortic valve replacement procedures. CT TAVI Planning is a…
Read the full statement (180 words)
The CT TAVI Planning application is intended to be used for patients with aortic valvular disease, severe symptomatic aortic stenosis or tricuspid aortic valve. The intended part of the body for this application is the human heart specifically the ascending aorta, aortic root, coronary ostia and left ventricle in order to assess the aortic valve in pre-operational planning of transcatheter aortic valve replacement procedures.
CT TAVI Planning is a non-invasive post-processing application providing 3D model-based segmentation of the aortic valve and aortic arch. The CT TAVI Planning application provides assessment and measurements of relevant heart structures for TAVI-device sizing, and allows the user to select a starting angle for C-arm position from the possible optimal positions from the CT TAVI and select a C-arm angle the user feels is appropriate to use in the catheterization laboratory by the Interventional team performing the procedure (to be used during the procedure itself).
The physician retains the ultimate responsibility for making the determination of patient eligibility or which device is implanted based on their standard practices and additional imaging modalities such as echocardiography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132524: CT Transcatheter Aortic Valve Implantation (Tavi) Planning Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132524
Report an extraction error
Are you the manufacturer?
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