510(k) K113350 ยท KPS System, Tomography, Computed, Emission
BRIVO NM 615
| Applicant | GE Healthcare, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Dec 5, 2011 |
| Received | Nov 14, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113350
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Brivo NM 615, Model/Catalog Numbers:
1) 5376204-15,
2) H2401MA,
3) H3100TA; 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) BRIVO B615 3/8 inch DHP BJG NR,
b) BRIVO 615 3/8 inch,
c) BRIVO B615 3/8 inch DHP BJG NR,
d) B615 with new rotor,
e) BRIVO B615 3/8 i Open, Classified |
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 Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system.
Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and dis Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.