510(k) K173816 ยท KPS System, Tomography, Computed, Emission
NM/CT 850, NM/CT 860
| Applicant | GE Healthcare, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Apr 17, 2018 |
| Received | Dec 15, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173816
| 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) 850,
b) 850 / Dismount,
c) 850 3/8 inch NM Gantry,
d) 860 / Dismount,
e) 860 3/8 inch NM Gantry,
f) 860 5/8 inch NM Gantry,
g) 860 BJ Open, Classified |
KPS | None listed |
| May 11, 2021 | GE Healthcare, LLC NM/CT 850 Nuclear Medicine / CT Scanners Open, Classified |
KPS | None listed |
| May 11, 2021 | GE Healthcare, LLC NM/CT 860 Nuclear Medicine / CT Scanners Open, Classified |
KPS | None listed |
| Dec 10, 2020 | GE Healthcare, LLC GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. Terminated |
KPS | None listed |
| Dec 10, 2020 | GE Healthcare, LLC GE NM/CT 860 system Model Number H3908AD - 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 850
Model Number: H3907AD Terminated |
KPS | None listed |
| Aug 14, 2020 | GE Healthcare, LLC NM/CT 860, SPECT/CT Terminated |
KPS | None listed |
| Mar 20, 2019 | GE Healthcare, LLC NM 830
Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake Terminated |
JAK | None listed |
| Mar 20, 2019 | GE Healthcare, LLC NM/CT 850
Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general pu Terminated |
JAK | None listed |
| Mar 20, 2019 | GE Healthcare, LLC NM/CT 860
Product Usage:
The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.