510(k) K884268 ยท JAK System, X-Ray, Tomography, Computed
VOXELSCOPE(TM)
| Applicant | Dynamic Digital Displays, Inc., Philadelphia PA, US |
| Decision | Substantially Equivalent, Dec 20, 1988 |
| Received | Oct 11, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884268
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2007 | Philips Medical Systems (Cleveland) Inc Philips, Voxel Q workstations, untilizing AcQSim or AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 and any Mx8000, Mx8001DT, or Brilliance 6, 10, 16, 16P Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.