510(k) K244008 ยท JAK System, X-Ray, Tomography, Computed
Spectral CT
| Applicant | Philips Medical Systems Technologies , Ltd., Haifa, IL |
| Decision | Substantially Equivalent, May 16, 2025 |
| Received | Dec 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K244008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2026 | PHILIPS MEDICAL SYSTEMS Spectral CT and Spectral CT 7500 RT;
Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.);
Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 ( Open, Classified |
JAK | None listed |
| Sep 29, 2026 | Philips North America Llc Philips Medical Systems
Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333 Open, Classified |
JAK | None listed |
| Feb 6, 2026 | Philips North America Llc Spectral CT;
Product Code (REF): 728333; Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.