510(k) · Cleared
ClearedPhilips CT 3500
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 Dec 22, 2022 as substantially equivalent to K212441 (Philips Healthcare (Suzhou) Co., Ltd., 2022) and 1 other predicate after a 55-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Dec 22, 2022
- Review
- 55 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K930090 (1993). 14 ancestors in all. No later device cites it as a predicate yet.
- 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 backK211168 Philips Incisive CT on TrailerPhilips Healthcare (Suzhou) Co., Ltd. · 2021 · Recalled
- This deviceK223311 Philips CT 3500Philips Healthcare (Suzhou) Co., Ltd. · 2022
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 | K211168 | Philips Incisive CT on Trailer | Philips Healthcare (Suzhou) Co., Ltd. | 2021 | 1 |
| 0 (this device) | 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 |
| 2022 | 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 |
|---|---|---|---|
| * | K212441 | Philips Incisive CTSummary page 5…Philips Healthcare (Suzhou) Co., Ltd. 510(k) Clearance: K212441, K211168 Classification Regulation: 21CFR 892.1750 Classification… | 2022 |
| * | K211168 | Philips Incisive CT on TrailerSummary page 5…Philips Healthcare (Suzhou) Co., Ltd. 510(k) Clearance: K212441, K211168 Classification Regulation: 21CFR 892.1750 Classification name:… | 2021 |
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 29 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 8 of the 14 ancestors have a recall of any class.
- 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. 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 Philips CT 3500 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 Philips CT 3500 is indicated for head, whole body, cardiac (Cardiac Calcium Scoring) and vascular X-ray Computed Tomography…
Read the full statement (157 words)
The Philips CT 3500 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 Philips CT 3500 is indicated for head, whole body, cardiac (Cardiac Calcium Scoring) 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/K223311 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223311: Philips CT 3500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223311
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