510(k) · Cleared
Recalled · Class II · 2026Philips Incisive CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Healthcare (Suzhou) Co., Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 27, 2022 as substantially equivalent to K160743 (Philips Medical Systems (Cleveland), Inc., 2016) and 1 other predicate after a 266-day review. Its family tree reaches back 7 generations to 1993. 3 later devices descend from it. It has been recalled 17 times.
- Decided
- Apr 27, 2022
- Review
- 266 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 17
- Predicates
- 2
Its longest line of descent runs back 7 generations to K930090 (1993). 12 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK930090 HelicatElscint, Inc. · 1993
- 6 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 5 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 4 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 2 generations backK160743 Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc. · 2016 · Recalled
- 1 generation backK180015 Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2018 · Recalled
- This deviceK212441 Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK232491 CT 5300Philips Healthcare (Suzhou) Co., Ltd. · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK252992 CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK223311 Philips CT 3500Philips Healthcare (Suzhou) Co., Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See all- K232491CT 5300Philips Healthcare (Suzhou) Co., Ltd. · 2024 · cites it directly1descendant
- K252992CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. · 2026 · 2 generations on0descendants
- K223311Philips CT 3500Philips Healthcare (Suzhou) Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −6 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −5 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −4 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −3 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −2 | K160743 | Philips Ingenuity CT | Philips Medical Systems (Cleveland), Inc. | 2016 | 24 |
| −1 | K180015 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | 2018 | 23 |
| 0 (this device) | K212441 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | 2022 | — |
| +1 | K232491 | CT 5300 | Philips Healthcare (Suzhou) Co., Ltd. | 2024 | 5 |
| +2 | K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026 | — |
| +1 | K223311 | Philips CT 3500 | Philips Healthcare (Suzhou) Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2022 | 1 | 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? (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…Philips Medical Systems (Cleveland), Inc. 510(k) Clearance: K160743 Classification Regulation: 21CFR 892.1750 Classification name:… | 2016 |
| * | K180015 | Philips Incisive CTSummary page 4…Philips Healthcare (Suzhou) Co., Ltd. 510(k) Clearance: K180015 Classification Regulation: 21CFR 892.1750 Classification name:… | 2018 |
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Jun 26, 2026 | Class II | Z-2988-2026 | Radiation Control for Health and Safety Act | Potential of failing to trigger clinical scan during Bolus Tracking. |
| Dec 3, 2025 | Class II | Z-1003-2026 | Radiation Control for Health and Safety Act | Potential for incomplete scan due to unstable connection inside of floating sensor. |
| Oct 29, 2025 | Class II | Z-0881-2026 | Under Investigation by firm | If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other… |
| Sep 25, 2025 | Class II | Z-0375-2026 | Under Investigation by firm | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation)… |
| Sep 25, 2025 | Class II | Z-0376-2026 | Under Investigation by firm | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation)… |
| Sep 25, 2025 | Class II | Z-0377-2026 | Under Investigation by firm | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation)… |
| Apr 15, 2024 | Class II | Z-1872-2024 | Under Investigation by firm | Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during… |
| Dec 7, 2023 | Class II | Z-0719-2024 | Component design/selection | If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG signal. Loss of ECG… |
| Aug 2, 2023 | Class II | Z-2520-2023 | Radiation Control for Health and Safety Act | Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan… |
| Apr 12, 2023 | Class II | Z-1625-2023 | Software design | Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required |
| Apr 12, 2023 | Class II | Z-1623-2023 | Software design | Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required |
| Apr 12, 2023 | Class II | Z-1622-2023 | Software design | Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required |
| Apr 12, 2023 | Class II | Z-1624-2023 | Software design | Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required |
| Mar 20, 2023 | Class II | Z-1585-2023 | Under Investigation by firm | Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury |
| Mar 20, 2023 | Class II | Z-1586-2023 | Under Investigation by firm | Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury |
| Dec 23, 2022 | Class II | Z-0640-2024 | Software design | Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation… |
| Mar 29, 2022 | Class II | Z-0576-2024 | Software design | Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use. |
The 5 latest of 17 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 29 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 6 of the 12 ancestors have a recall of any class.
- Of its descendants, K232491 (Philips Healthcare (Suzhou) Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 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. 2022, 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 Incisive 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 Incisive 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 Incisive 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 Incisive 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/K212441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212441: Philips Incisive CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212441
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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