510(k) K082816 ยท JAK System, X-Ray, Tomography, Computed
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Oct 8, 2008 |
| Received | Sep 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082816
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2018 | GE Healthcare, LLC Optima CT 540 Terminated |
JAK | None listed |
| Apr 27, 2018 | GE Healthcare Japan Corporation GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names:
BEIJING CT OPTIMA 540, Terminated |
JAK | None listed |
| Apr 27, 2018 | GE Healthcare Japan Corporation GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only outside the U.S. under the following product names: Terminated |
JAK | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Optima CT540 X-ray system Terminated |
JAK | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare BrightSpeed X-ray system Terminated |
JAK | None listed |
| Jan 27, 2014 | GE Healthcare, LLC GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems.
Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different an Terminated |
JAK | None listed |
| May 19, 2011 | GE Healthcare, LLC BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4.
The GE BrightSpeed Del Terminated |
JAK | None listed |
| Nov 15, 2010 | GE Healthcare, LLC GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image Terminated |
JAK | None listed |
| Nov 15, 2010 | GE Healthcare, LLC GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System, models 2377708-560, 5377708-540, 5377708-560. Composed of a gantry, patient table, operator console, computer, and PDU and includes i Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.