510(k) K121019 ยท KPS System, Tomography, Computed, Emission
OPTIMA NM/CT 640
| Applicant | GE Healthcare, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Apr 19, 2012 |
| Received | Apr 4, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121019
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Optima NM/CT 640, Model/Catalog Numbers:
1) H3100JZ; 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) OPTIMA O640 X 3/8 inch NR,
b) DISCOVERY O640 X 3/8 inch,
c) NM OPTIMA O640 X 3/8 inch,
d) O640 NM Gantry 3/8 inch,
e) O640 NM GANTRY F Open, Classified |
KPS | None listed |
| Dec 10, 2020 | GE Healthcare, LLC Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. Terminated |
KPS | None listed |
| Mar 20, 2019 | GE Healthcare, LLC Optima NM/CT 640
Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includ Terminated |
JAK | 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 Optima NM/CT 640
Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It incl Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.