510(k) K021491 ยท JAK System, X-Ray, Tomography, Computed
HISPEED DUAL
| Applicant | Ge Medical Systems, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, May 22, 2002 |
| Received | May 9, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021491
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2009 | GE Medical Systems, LLC GE Healthcare CT/e and HiSpeed X/i, families of computed tomography Systems with Gantry.
The CT/e and HiSpeed X/i families CT Scanner Systems are indicated for head and whole body X-ray Computed Tomo Terminated |
JAK | None listed |
| Feb 24, 2005 | General Electric Med Systems LLC Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series. Terminated |
IXR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.