510(k) K250648 ยท JAK System, X-Ray, Tomography, Computed
Philips iCT CT system
| Applicant | Philips Medical Systems Nederland B.V., Haifa, IL |
| Decision | Substantially Equivalent, Jun 27, 2025 |
| Received | Mar 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250648
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2026 | Philips North America Llc Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x
Product Codes: 728306, 728305, 728311. Open, Classified |
JAK | None listed |
| Jul 27, 2026 | PHILIPS MEDICAL SYSTEMS Brilliance iCT
Brilliance iCT Upgrades
Brilliance iCT SP
Brilliance CT 64 Channel
CT6000
Brilliance 64 Upgrades Open, Classified |
JAK | None listed |
| Feb 6, 2026 | Philips North America Llc Brilliance iCT;
Product Code (REF): 728306; Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.