510(k) · Cleared
Recalled · Class II · 2025CT 5300
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 May 3, 2024 as substantially equivalent to K212441 (Philips Healthcare (Suzhou) Co., Ltd., 2022) after a 260-day review. Its family tree reaches back 8 generations to 1993. 1 later device descends from it. It has been recalled 5 times.
- Decided
- May 3, 2024
- Review
- 260 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 8 generations to K930090 (1993). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK930090 HelicatElscint, Inc. · 1993
- 7 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 6 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 5 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 3 generations backK160743 Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc. · 2016 · Recalled
- 2 generations backK180015 Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2018 · Recalled
- 1 generation backK212441 Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2022 · Recalled
- This deviceK232491 CT 5300Philips Healthcare (Suzhou) Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK252992 CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252992CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −7 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −6 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −5 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −4 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −3 | K160743 | Philips Ingenuity CT | Philips Medical Systems (Cleveland), Inc. | 2016 | 24 |
| −2 | K180015 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | 2018 | 23 |
| −1 | K212441 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | 2022 | 17 |
| 0 (this device) | K232491 | CT 5300 | Philips Healthcare (Suzhou) Co., Ltd. | 2024 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K212441 | Philips Incisive CTSummary page 4…r: Philips Healthcare (Suzhou) Co., Ltd. 510(k) Clearance: K212441 Classification Regulation: 21CFR 892.1750 Classification name:… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2025 | Class II | Z-0882-2026 | 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… |
| 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)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 7 of the 13 ancestors have a recall of any class.
- Of its descendants, K252992 (Philips Healthcare (Suzhou) Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K212441.
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. 2024, 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 5300 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 CT 5300 is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. These…
Read the full statement (152 words)
The CT 5300 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 CT 5300 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/K232491 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232491: CT 5300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232491
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