510(k) · Cleared
Recalled · Class II · 2026Philips Ingenuity CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 8, 2016 as substantially equivalent to K033326 (Philips Medical Systems, Inc., 2003) after a 144-day review. Its family tree reaches back 5 generations to 1993. 9 later devices descend from it. It has been recalled 24 times.
- Decided
- Aug 8, 2016
- Review
- 144 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 24
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930090 (1993). 10 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK930090 HelicatElscint, Inc. · 1993
- 4 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 3 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 2 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- This deviceK160743 Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc. · 2016
- Descendant · cites it directly · 7 of its ownK180015 Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2018 · Recalled
- Descendant · cites it directly · 3 of its ownK212441 Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK232491 CT 5300Philips Healthcare (Suzhou) Co., Ltd. · 2024 · Recalled
- Descendant · 2 generations on · 1 of its ownK211168 Philips Incisive CT on TrailerPhilips Healthcare (Suzhou) Co., Ltd. · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK252992 CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K180015Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2018 · cites it directly7descendants
- K212441Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2022 · cites it directly3descendants
- K232491CT 5300Philips Healthcare (Suzhou) Co., Ltd. · 2024 · 2 generations on1descendant
- K211168Philips Incisive CT on TrailerPhilips Healthcare (Suzhou) Co., Ltd. · 2021 · 2 generations on1descendant
- K252992CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −4 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −3 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −2 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −1 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| 0 (this device) | K160743 | Philips Ingenuity CT | Philips Medical Systems (Cleveland), Inc. | 2016 | — |
| +1 | K180015 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | 2018 | 23 |
| +1 | K212441 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | 2022 | 17 |
| +2 | K232491 | CT 5300 | Philips Healthcare (Suzhou) Co., Ltd. | 2024 | 5 |
| +2 | K211168 | Philips Incisive CT on Trailer | Philips Healthcare (Suzhou) Co., Ltd. | 2021 | 1 |
| +3 | K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K033326 | Philips Plus Computed Tomography SystemSummary page 6…92.1750 Class: II Product Code: JAK Panel: Radiology Primary Predicate device K033326 – Philips Plus CT Scanner Premarket Notification [510(k)] Submission Philips Medical Systems (Cleveland), Inc.… | 2003 |
| † | K131773 | Brilliance Ict | 2013 |
| † | K033357 | Acqsim-Multislice-CT, Model 453567042271 | 2004 |
| † | K060937 | Brilliance Volume | 2006 |
| † | K123599 | Ingenuity Digital Pet/CT | 2013 |
| † | K133674 | Philips Iqon Spectral CT | 2014 |
| † | K123576 | Imr Software Application | 2013 |
| † | K091195 | Philips MX 16 Slice CT System PHASE11, Model 9896 056 56511 | 2009 |
| † | K033677 | Brain Perfusion Option | 2004 |
| † | K042293 | Brilliance CT, Private Practice CV Configuration, CT Scanner | 2004 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2026 | Class II | Z-3042-2026 | Radiation Control for Health and Safety Act | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. |
| Jun 11, 2026 | Class II | Z-2652-2026 | Radiation Control for Health and Safety Act | The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis… |
| Aug 13, 2025 | Class II | Z-2600-2025 | Process control | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Jun 8, 2021 | Class II | Z-2315-2021 | Software design | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient. |
| Jun 8, 2021 | Class II | Z-2316-2021 | Software design | When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient. |
| May 1, 2021 | Class II | Z-1984-2021 | Device Design | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining… |
| Jun 24, 2019 | Class II | Z-2188-2019 | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied |
| Jun 24, 2019 | Class II | Z-2186-2019 | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied |
| Jun 24, 2019 | Class II | Z-2187-2019 | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied |
| Mar 28, 2018 | Class II | Z-2277-2018 | Other | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users. |
| Mar 28, 2018 | Class II | Z-2274-2018 | Other | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users. |
| Mar 28, 2018 | Class II | Z-2275-2018 | Other | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users. |
| Nov 10, 2017 | Class II | Z-0390-2018 | Under Investigation by firm | Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the… |
| Nov 10, 2017 | Class II | Z-0391-2018 | Under Investigation by firm | Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the… |
| Oct 6, 2017 | Class II | Z-0520-2018 | Software design | Numerous issues related to software Brilliance iCT 4.1.6 software version. |
| Oct 6, 2017 | Class II | Z-0518-2018 | Software design | Numerous issues related to software Brilliance iCT 4.1.6 software version. |
| Oct 6, 2017 | Class II | Z-0519-2018 | Software design | Numerous issues related to software Brilliance iCT 4.1.6 software version. |
| Oct 6, 2017 | Class II | Z-0521-2018 | Software design | Numerous issues related to software Brilliance iCT 4.1.6 software version. |
| Nov 12, 2016 | Class II | Z-0695-2017 | Software design | Software error due to the filament on timer |
| Nov 12, 2016 | Class II | Z-0697-2017 | Software design | Software error due to the filament on timer |
| Nov 12, 2016 | Class II | Z-0696-2017 | Software design | Software error due to the filament on timer |
| Oct 13, 2016 | Class III | Z-0595-2017 | Labeling Change Control | The product label does not include the correct current rating. |
| Oct 13, 2016 | Class III | Z-0597-2017 | Labeling Change Control | The product label does not include the correct current rating. |
| Oct 13, 2016 | Class III | Z-0596-2017 | Labeling Change Control | The product label does not include the correct current rating. |
The 5 latest of 24 recalls; the web page lists all.
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 3.0 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K180015 (Philips Healthcare (Suzhou) Co., Ltd., 2018) has gone furthest, with 7 descendants of its own.
- 8 other devices also cite its predicate K033326.
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. 2016, 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 Ingenuity CT is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. The Ingenuity CT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.…
Read the full statement (152 words)
The Ingenuity CT is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. The Ingenuity CT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160743 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160743: Philips Ingenuity CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160743
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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