510(k) K081496 ยท KPS System, Tomography, Computed, Emission
OPTIMA PET/CT 560
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Jun 12, 2008 |
| Received | May 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081496
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2019 | GE Healthcare, LLC Discovery PET/CT 610
Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission
Tomography (PET) imaging and localization of emission activity in patient Open, Classified |
KPS | None listed |
| Jun 19, 2019 | GE Healthcare, LLC Optima PET/CT 560, 560FX
Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission
Tomography (PET) imaging and localization of emission activity in pat Open, Classified |
KPS | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system Terminated |
KPS | None listed |
| Feb 10, 2016 | GE Medical Systems, LLC LightSpeed 16 (MDAS only
, , 2339985
LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery Terminated |
KPS | None listed |
| Feb 14, 2014 | GE Healthcare, LLC GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690.
The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomog Terminated |
KPS | None listed |
| Oct 17, 2013 | GE Healthcare, LLC GE PET Discovery 610, PET Discovery 710.
Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging. Terminated |
KPS | None listed |
| Apr 29, 2013 | GE Healthcare, LLC GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD.
Intended to produce cross-sectional images of the body by computer reconstruction of x-ray tr Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.