510(k) K153402 ยท KPS System, Tomography, Computed, Emission
Discovery NM/CT 670 CZT
| Applicant | GE Healthcare, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Jan 21, 2016 |
| Received | Nov 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153402
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2023 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Nuclear Medicine 600/800 series systems, specifically:
a) 870 CZT O540+ Gantry 7.25mm,
b) D670 CZT Gantry 7.25mm,
c) DISCOV NM/CT 870 CZT,
d) Discovery NMCT 670 CZT O540+,
e) NM/CT 870 CZT CYB Open, Classified |
KPS | None listed |
| Dec 10, 2020 | GE Healthcare, LLC GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. Terminated |
KPS | None listed |
| Aug 14, 2020 | GE Healthcare, LLC NM/CT 870 CZT
Model # H3906CW Terminated |
KPS | None listed |
| Mar 20, 2019 | GE Healthcare, LLC Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT
Product Usage:
The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tr Terminated |
JAK | None listed |
| Mar 20, 2019 | GE Healthcare, LLC NM/CT 870 CZT, Model/Catalogue/Code # H3906CW
Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer up Terminated |
JAK | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Discovery NM/CT 670 CZT X-ray system Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.