510(k) K093514 ยท KPS System, Tomography, Computed, Emission
DISCOVERY MODEL NM/CT 670
| Applicant | Ge Medical Systems F.I. Haifa, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Dec 10, 2009 |
| Received | Nov 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093514
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers:
1) 5376204-70-54-2,
2) H2401BC,
3) H2401CE,
4) H2401CG,
5) H3100AG,
6) H3100JW,
7) H3100NC; System, Tomography, Computed, Emission Open, Classified |
KPS | None listed |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers:
1) 5376204-70-54-2;
2) H2401AK;
3) H2402AC;
4) H3100AH;
5) H3100XB; System, Tomography, Computed, Emission Open, Classified |
KPS | None listed |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers:
1) H3100XF ; System, Tomography, Computed, Emission Open, Classified |
KPS | None listed |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers:
1) H3906AB; System, Tomography, Computed, Emission Open, Classified |
KPS | None listed |
| Feb 8, 2023 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Nuclear Medicine 600/800 series systems, specifically:
a) 870,
b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA,
c) 870 DR / Dismount,
d) 870 DR / Dismount / 60HZ,
e) 870 DR 3/8 inch WSO,
Open, Classified |
KPS | None listed |
| May 11, 2021 | GE Healthcare, LLC NM/CT 870 DR Nuclear Medicine / CT Scanners Open, Classified |
KPS | None listed |
| Dec 10, 2020 | GE Healthcare, LLC Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately traine Terminated |
KPS | None listed |
| Aug 14, 2020 | GE Healthcare, LLC Discovery 670 DR
Model # H3100BT Terminated |
KPS | None listed |
| Aug 14, 2020 | GE Healthcare, LLC Discovery NM670 Pro
Model # H3100XB Terminated |
KPS | None listed |
| Aug 14, 2020 | GE Healthcare, LLC NM/CT 870 DR
Model # H3100AS Terminated |
KPS | None listed |
| Mar 20, 2019 | GE Healthcare, LLC Discovery NM/CT 670 DR
Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing o Terminated |
JAK | None listed |
| Mar 20, 2019 | GE Healthcare, LLC Discovery NM/CT 670 ES
Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of Terminated |
JAK | None listed |
| Mar 20, 2019 | GE Healthcare, LLC NM/CT 870 DR
Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases Terminated |
JAK | None listed |
| May 24, 2018 | GE Healthcare, LLC Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders s Completed |
KPS | None listed |
| May 24, 2018 | GE Healthcare, LLC Discovery NM/CT 670 ES, model 5376204-70-57 Completed |
KPS | None listed |
| May 24, 2018 | GE Healthcare, LLC Discovery NM/CT 670 Pro, model 5376204-70-54 Completed |
KPS | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system Terminated |
KPS | None listed |
| Nov 20, 2013 | GE Healthcare, LLC GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615.
The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professio Terminated |
KPS | None listed |
| Jul 24, 2013 | GE Healthcare, LLC Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system.
Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained hea Terminated |
KPS | None listed |
| Oct 23, 2012 | GE Healthcare, LLC GE Discovery NM/CT670; GE Discovery NM 630
Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases a Terminated |
KPS | None listed |
| Feb 27, 2012 | GE Healthcare, LLC GE Discovery NM/CT 670
The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases a Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.