510(k) K132410 ยท JAK System, X-Ray, Tomography, Computed
DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Jan 17, 2014 |
| Received | Aug 2, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132410
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2018 | GE Healthcare, LLC Discovery RT labeled as:
a. MID BJG;
b. HVY BJG Terminated |
JAK | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Optima CT580; Discovery RT, CT590 RT 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.