510(k) K160743 ยท JAK System, X-Ray, Tomography, Computed
Philips Ingenuity CT
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Aug 8, 2016 |
| Received | Mar 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160743
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2026 | Philips North America Llc Philips Ingenuity CT
Product Codes: Ingenuity CT Upgrades 728327,
Ingenuity CT China 728324,
Ingenuity Core 128 Elite Brazil 728325.
Software 4.4.10.x Open, Classified |
JAK | None listed |
| Jul 27, 2026 | PHILIPS MEDICAL SYSTEMS Ingenuity CT
CT5000 Ingenuity Plus
CT5000 Ingenuity Pro
CT5000 Ingenuity Premium
Ingenuity CT Upgrades
Ingenuity CT China
Ingenuity Core 128 Elite Brazil Open, Classified |
JAK | None listed |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Ingenuity CT 728326, Model Number: 728321.
2. Ingenuity CT 728326, Model Number: 728323.
3. Ingenuity CT, Model Number: 728326. Open, Classified |
JAK | None listed |
| Jun 8, 2021 | Philips North America Llc Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system Terminated |
JAK | None listed |
| Jun 8, 2021 | Philips North America Llc 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system Terminated |
JAK | None listed |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
Ingenuity Core, Ingenuity Core 128, Ingenuity CT
728321 - Ingenuity Core
728323 - Ingenuity Core 128
728326/728327 - Ingenu Open, Classified |
JAK | None listed |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Ingenuity CT,
Model # 728326, computed tomography x-ray system Terminated |
JAK | None listed |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Ingenuity Core128
Model # 728323, computed tomography x-ray system Terminated |
JAK | None listed |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Ingenuity Core
Model # 728321, computed tomography x-ray system Terminated |
JAK | None listed |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Philips Ingenuity Core 728321 Terminated |
JAK | None listed |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity Core128 728323 Terminated |
JAK | None listed |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity Core128/Elite China 728324 Terminated |
JAK | None listed |
| Nov 10, 2017 | Philips Medical Systems (Cleveland) Inc Ingenuity Core, (Code 728321)
Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. Terminated |
JAK | None listed |
| Nov 10, 2017 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128, (Code 728323)
Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. Terminated |
JAK | None listed |
| Oct 6, 2017 | Philips Medical Systems (Cleveland) Inc Philips Brilliance 64 computed tomography x-ray system Terminated |
JAK | None listed |
| Oct 6, 2017 | Philips Medical Systems (Cleveland) Inc Philips Ingenuity Core computed tomography x-ray system Terminated |
JAK | None listed |
| Oct 6, 2017 | Philips Medical Systems (Cleveland) Inc Philips Ingenuity Core 128 computed tomography x-ray system Terminated |
JAK | None listed |
| Oct 6, 2017 | Philips Medical Systems (Cleveland) Inc Philips Ingenuity CT computed tomography x-ray system Terminated |
JAK | None listed |
| Nov 12, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 728321
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and plane Terminated |
JAK | None listed |
| Nov 12, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 728323 Terminated |
JAK | None listed |
| Nov 12, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity CT 728326
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Terminated |
JAK | None listed |
| Oct 13, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity CT Computed Tomography X-ray system, Model 728326 Terminated |
JAK | None listed |
| Oct 13, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 Computed Tomography X-ray system, Model 728323 Terminated |
JAK | None listed |
| Oct 13, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core Computed Tomography X-ray system, Model 728321 Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.