510(k) K022960 ยท KPS System, Tomography, Computed, Emission
GE QUASAR NUCLEAR MEDICINE SYSTEM
| Applicant | Ge Medical Systems F.I. Haifa, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Sep 19, 2002 |
| Received | Sep 6, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022960
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system Open, Classified |
KPS | None listed |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Infinia I, Model/Catalog Numbers:
1) 5178728,
2) H3000WE,
3) H3000WM,
4) H3000YG; System, Tomography, Computed, Emission Open, Classified |
KPS | None listed |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Infinia II, Model/Catalog Numbers:
1) H2799ZP;
2) H3000WT; System, Tomography, Computed, Emission Open, Classified |
KPS | None listed |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers:
1) H3000WN;
2) H3000YM;
3) H3000YS; System, Tomography, Computed, Emission Open, Classified |
KPS | None listed |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers:
1) H2799PP;
2) H2799PR;
3) H2799YC;
4) H2799YD;
5) H3000WC;
6) H3000WD;
7) H3000WT;
8) H3000WW;
9) H3000WY;
10) H3000WZ; System, T Open, Classified |
KPS | None listed |
| 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 |
| Mar 13, 2014 | GE Healthcare, LLC GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nucl Terminated |
KPS | None listed |
| Mar 13, 2014 | GE Healthcare, LLC GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer upta Terminated |
KPS | None listed |
| Mar 13, 2014 | GE Healthcare, LLC Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detecti 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 |
| Apr 21, 2009 | GE Medical Systems, LLC GE Healthcare Infinia, Model Numbers: ASM000886, ASM001391, ASM001333, ASM001465, ASM001473, ASM001620, ASM500016, H3000WM, H3000WT, H3000WY and SYS000041.
Product is used to perform general Nuclear Terminated |
KPS | None listed |
| Apr 21, 2009 | GE Medical Systems, LLC GE Healthcare Infinia Hawkeye, Model Numbers: H3000WR, H3000WW, H3000WZ, H3000YM and H3000YS.
Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope trac Terminated |
KPS | None listed |
| Apr 21, 2009 | GE Medical Systems, LLC GE Healthcare Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD.
Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer u Terminated |
KPS | None listed |
| Apr 10, 2009 | GE Medical Systems, LLC GE Healthcare, Infinia, Model Numbers:
ASM000886
ASM001391
ASM001333
ASM001465
ASM001473
ASM001620
ASM500016
H3000WM
H3000WT
H3000WY and
SYS000041.
The device is used to perform general Nu Terminated |
KPS | None listed |
| Apr 10, 2009 | GE Medical Systems, LLC GE Healthcare, Hawkeye for Infinia, Model Numbers: H3000WR , H3000WW, H3000WZ , H3000YM and H3000YS.
The device is used to perform general Nuclear Medicine imaging procedures for detection of radioi Terminated |
KPS | None listed |
| Apr 10, 2009 | GE Medical Systems, LLC GE Healthcare, Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060,
H3000WC and H3000WD.
The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tr Terminated |
KPS | None listed |
| Apr 10, 2009 | GE Medical Systems, LLC GE Healthcare Infinia Hawkeye(R), Model numbers:
H2508PY
H3000WN
H3000WR
H3000WW
H3000WY
H3000WZ
H3000YM
H3000YS
Intended use: To perform general Nuclear Medicine imaging procedures for dete Terminated |
KPS | None listed |
| Apr 10, 2009 | GE Medical Systems, LLC GE Healthcare Infinia Hawkeye(R) 4, Model numbers:
H3000WC
H3000WD
Intended use: To perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient bo Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.