510(k) K093581 ยท JAK System, X-Ray, Tomography, Computed
DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Apr 19, 2011 |
| Received | Nov 18, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093581
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as: Open, Classified |
JAK | None listed |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA:
EU: RT Refresh Package,
Non-EU: Discovery RT, Optima CT580, or
Discovery CT590 RT; X-ray/computed tomography system Open, Classified |
JAK | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system Terminated |
JAK | None listed |
| Mar 20, 2014 | GE Healthcare, LLC GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3.
The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross- Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.