Company ยท IL
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2025. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
41recalls (5 in 12 months)
29recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 17, 2025 | K243605 | Aurora Ge Medical Systems Israel, Functional Imaging, IL | KPS |
| Jan 3, 2025 | K241350 | Clarify DL Ge Medical Systems Israel, Functional Imaging, IL | LLZ |
| Aug 8, 2024 | K241665 | Omni Legend Ge Medical Systems Israel, Functional Imaging, IL | KPS |
| Nov 3, 2010 | K102231 | DISCOVERY NM 750B Ge Medical Systems Israel, Functional Imaging, IL | IYX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2026 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Omni Legend, sold under the following names:
OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Ga Completed |
KPS | K221932 K241665 |
| Jan 9, 2026 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING MAXXUS,
System, Tomography, Computed, Emission Open, Classified |
KPS | K924498 |
| Jan 9, 2026 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING SMV BodyTrack,
System, Tomography, Computed, Emission Open, Classified |
IYX | K911346 |
| Jan 9, 2026 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING SMV DSI,
System, Tomography, Computed, Emission Open, Classified |
KPS | K002553 |
| Jan 9, 2026 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING SMV DSX New Line,
System, Tomography, Computed, Emission Open, Classified |
IYX | K894931 |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | None listed |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | None listed |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | None listed |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | None listed |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Millenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | None listed |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | None listed |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | None listed |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | None listed |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | None listed |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | None listed |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | None listed |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | K932673 |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | K884674 |
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | K952674 |
| Jul 8, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System Open, Classified |
KPS | K953801 |
| Jul 8, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system Open, Classified |
KPS | K022960 |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers:
1) ASM000085;
2) ASM001092;
3) SYS000001; System, Tomography, Computed, Emission Open, Classified |
KPS | K953801 |
| 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 | K022960 |
| 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 | K022960 |
| 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 | K022960 |
| 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 | K121019 |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers:
1) H3906AB; System, Tomography, Computed, Emission Open, Classified |
KPS | K093514 |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers:
1) H3100XF ; System, Tomography, Computed, Emission Open, Classified |
KPS | K093514 |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers:
1) 5376204-70-54-2;
2) H2401AK;
3) H2402AC;
4) H3100AH;
5) H3100XB; System, Tomography, Computed, Emission Open, Classified |
KPS | K093514 |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers:
1) 5376204-70-56-2;
2) H2401AW;
3) H3100AN;
4) H3100BT;
5) H3100PX; System, Tomography, Computed, Emission Open, Classified |
KPS | None listed |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers:
1) 5376204-70-54-2,
2) H2401BC,
3) H2401CE,
4) H2401CG,
5) H3100AG,
6) H3100JW,
7) H3100NC; System, Tomography, Computed, Emission Open, Classified |
KPS | K093514 |
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Discovery NM 630, Model/Catalog Numbers:
1) 5376204-30-2,
2) H2401CF,
3) H2401CH,
4) H2401JE,
5) H3100JY; System, Tomography, Computed, Emission Open, Classified |
KPS | K111445 |
| 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 | K113350 |
| 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 | K022960 |
| Jun 7, 2024 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system). Open, Classified |
KPS | K212004 |
| 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 | K173816 |
| Feb 8, 2023 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Nuclear Medicine 600/800 series systems, specifically:
a) 870 CZT O540+ Gantry 7.25mm,
b) D670 CZT Gantry 7.25mm,
c) DISCOV NM/CT 870 CZT,
d) Discovery NMCT 670 CZT O540+,
e) NM/CT 870 CZT CYB Open, Classified |
KPS | K153402 |
| 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 | K121019 |
| 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 | K113350 |
| Feb 8, 2023 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Nuclear Medicine 600/800 series systems, specifically:
a) 830,
b) 830 / Dismount,
c) 830 /,
d) 830 / 5842894-20,
e) 830 / Dismount / 50HZ,
f) 830 / Dismount / 60HZ,
g) 830 3/8 inch Detector Open, Classified |
KPS | K111445 |
| Feb 8, 2023 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Nuclear Medicine 600/800 series systems, specifically:
a) 870,
b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA,
c) 870 DR / Dismount,
d) 870 DR / Dismount / 60HZ,
e) 870 DR 3/8 inch WSO,
Open, Classified |
KPS | K093514 |