510(k) K212441 ยท JAK System, X-Ray, Tomography, Computed
Philips Incisive CT
| Applicant | Philips Healthcare (Suzhou) Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Apr 27, 2022 |
| Received | Aug 4, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212441
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2026 | Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144. Open, Classified |
JAK | None listed |
| Jan 8, 2026 | Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT Open, Classified |
JAK | None listed |
| Dec 3, 2025 | Philips North America Llc Incisive CT;
Software Version Number: 4.5, 5.0, 5.1; Open, Classified |
JAK | None listed |
| Oct 27, 2025 | PHILIPS MEDICAL SYSTEMS Model: Incisive CT;
Product Code (REF): (1) 728143, (2) 728144;
Software Versions: 5.1.0.X & 5.1.1.X; Open, Classified |
JAK | None listed |
| Oct 27, 2025 | PHILIPS MEDICAL SYSTEMS Model: CT 5300;
Product Code (REF): 728285;
Software Versions: 5.1.0.X & 5.1.1.X; Open, Classified |
JAK | None listed |
| Oct 27, 2025 | PHILIPS MEDICAL SYSTEMS Model: Incisive CT for Brazil SKD;
Product Code (REF): 728146;
Software Versions: 5.1.0.X & 5.1.1.X; Open, Classified |
JAK | None listed |
| May 20, 2024 | Philips North America Llc Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body.
Model Number: 728144 Open, Classified |
JAK | None listed |
| Jan 12, 2024 | Philips North America Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System
PIM cable part number 459801179871 Open, Classified |
JAK | None listed |
| Jan 5, 2024 | Philips Healthcare (Suzhou) Co., Ltd. Incisive CT, model 728143 & 728144 running Software Version 5.0.0. Open, Classified |
JAK | None listed |
| Dec 18, 2023 | Philips North America Llc The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system a Completed |
JAK | None listed |
| Sep 30, 2023 | Philips Healthcare Incisive CT, software version 5.0 Open, Classified |
JAK | None listed |
| May 23, 2023 | PHILIPS HEADQUARTERS CAMBRIDGE Incisive CT- whole-body computed tomography (CT) X-Ray System
Model Number: 728144 Open, Classified |
JAK | None listed |
| May 23, 2023 | PHILIPS HEADQUARTERS CAMBRIDGE Incisive CT- Whole-body computed tomography (CT) X-Ray System
Model Number: 728143 (OUS) Open, Classified |
JAK | None listed |
| May 23, 2023 | PHILIPS HEADQUARTERS CAMBRIDGE Incisive CT Power- Whole-body computed tomography (CT) X-Ray System
Model Number: 728148 (OUS) Open, Classified |
JAK | None listed |
| May 23, 2023 | PHILIPS HEADQUARTERS CAMBRIDGE Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System
Model Number: 728149 (OUS) Open, Classified |
JAK | None listed |
| May 12, 2023 | Philips North America Philips Incisive CT -Computed Tomography X-Ray System
Model Number: 72814 Open, Classified |
JAK | None listed |
| May 12, 2023 | Philips North America Philips Incisive CT -Computed Tomography X-Ray System
Model Number: 72813 Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.