510(k) K082104 ยท JAK System, X-Ray, Tomography, Computed
GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM
| Applicant | Ge Medical Systems, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Sep 2, 2008 |
| Received | Jul 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082104
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Lightspeed RT16 X-ray system Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.