510(k) K091673 ยท JAK System, X-Ray, Tomography, Computed
GE LIGHTSPEED ACT FP16
| Applicant | Ge Medical Systems, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Jun 24, 2009 |
| Received | Jun 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091673
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2017 | GE Healthcare, LLC GE Healthcare lnnova IGS 540 ACT 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.