510(k) K042428 ยท KPS System, Tomography, Computed, Emission
SCEPTREP3 PET/CT
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Sep 17, 2004 |
| Received | Sep 8, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K042428
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2006 | Hitachi Medical Systems America Inc Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT) Terminated |
JAK | None listed |
| Jun 3, 2006 | Hitachi Medical Systems America Inc Hitachi Emission Computed Tomography System
Hitachi CX-4 CT (including SceptreP3 PET-CT) Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.