510(k) K012313 ยท JAK System, X-Ray, Tomography, Computed
CT COLONOGRAPHY/NAVIGATOR2
| Applicant | Ge Medical Systems, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Aug 7, 2001 |
| Received | Jul 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012313
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2012 | GE Healthcare, LLC GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)
The Advantage CT/PET Fusion clinical application provides Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.