510(k) K991841 ยท KPS System, Tomography, Computed, Emission
HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
| Applicant | Ge Medical Systems F.I. Haifa, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Aug 26, 1999 |
| Received | May 28, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991841
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | GE Healthcare, LLC GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3 Terminated |
KPS | None listed |
| Dec 16, 2014 | GE Healthcare, LLC GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD.
Product Usage: The intended use of the Quasar system is to perform Terminated |
KPS | None listed |
| Dec 16, 2014 | GE Healthcare, LLC Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS.
Product Usage: The GE Discovery NM/CT 670 system is Terminated |
KPS | None listed |
| Dec 16, 2014 | GE Healthcare, LLC Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW.
Product Usage: The GE Discovery NM 630 system is a medical tool intended for use Terminated |
KPS | None listed |
| Dec 16, 2014 | GE Healthcare, LLC Optima NM/CT 640, Models H3100YA, H3100YC.
Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in Terminated |
KPS | None listed |
| Dec 16, 2014 | GE Healthcare, LLC Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ.
P Terminated |
KPS | None listed |
| Jul 24, 2013 | GE Healthcare, LLC GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Terminated |
KPS | None listed |
| Apr 10, 2013 | GE Healthcare, LLC GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, al Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.