510(k) K040902 ยท JAK System, X-Ray, Tomography, Computed
HITACHI PRESTO
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Apr 21, 2004 |
| Received | Apr 7, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K040902
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2009 | Hitachi Medical Systems America Inc Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less. Terminated |
JAK | None listed |
| Jan 8, 2009 | Hitachi Medical Systems America Inc Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, an Terminated |
JAK | None listed |
| 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.