510(k) K232491 ยท JAK System, X-Ray, Tomography, Computed
CT 5300
| Applicant | Philips Healthcare (Suzhou) Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, May 3, 2024 |
| Received | Aug 17, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232491
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2025 | Philips North America Llc Incisive CT;
Software Version Number: 4.5, 5.0, 5.1; Open, Classified |
JAK | None listed |
| Dec 3, 2025 | Philips North America Llc CT 5300;
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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.