System, Tomography, Computed, Emission
Regulation 892.1200
9510(k)s in 12 months (473 all time)
9recalls in 12 months (450 all time)
435recalls that name a 510(k)
Top companies in KPS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI 780 Open, Classified |
KPS | K172143 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software Open, Classified |
KPS | K251839 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software Open, Classified |
KPS | K241596 K243538 +1 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software Open, Classified |
KPS | K231572 K241585 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software Open, Classified |
KPS | K223325 K232712 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software Open, Classified |
KPS | K182237 K193241 |
| 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 DSI,
System, Tomography, Computed, Emission Open, Classified |
KPS | K002553 |
| 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 |
| Dec 12, 2024 | Hermes Medical Solutions AB Hybrid Recon software on Hermes Medical Imaging Suite version 6.1
Hybrid Recon software versions affected are 4.0.0x and 5.0.0 Open, Classified |
KPS | K171681 |
| Nov 1, 2024 | Canon Medical System, USA, INC. Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Open, Classified |
KPS | K231748 |
| 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 2, 2024 | Philips North America BrightView XCT, gamma camera for SPECT;
Model Nos.:
6-digit format 882482;
12-digit format 453560462131
453560749161 Open, Classified |
KPS | K080927 |
| Feb 2, 2024 | Philips North America BrightView X, gamma camera for SPECT;
Model Nos.:
6-digit format 882478;
12-digit format 453560824741
453560829261; Open, Classified |
KPS | K080927 |
| Feb 2, 2024 | Philips North America BrightView, gamma camera system;
Model Nos.:
6-digit format 882480;
12-digit format 453560279781
453560279791
453560279811
453560279801;
4x4 digit format
2170-3000A
2170-3001A
2170-3002A
2170-3003A Open, Classified |
KPS | K062298 |
| Jan 5, 2024 | Philips North America BrightView XCT, Gamma Camera, Product Code 882482 Open, Classified |
KPS | K080927 |
| Jan 5, 2024 | Philips North America BrightView X, Gamma Camera, Product Code 882478 Open, Classified |
KPS | K080927 |
| Jan 5, 2024 | Philips North America BrightView, Gamma Camera System, Product Code 882480. Open, Classified |
KPS | K062298 |
| Jul 28, 2023 | Siemens Medical Solutions USA, Inc. The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly:
(a) Symbia Pro.specta Q3, Model 11364751;
(b) Symbia Pro.specta X Open, Classified |
KPS | K212604 |
| Apr 7, 2023 | Shanghai United Imaging Healthcare Co., Ltd. Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550
Part Number:
88000657
88000057 Open, Classified |
KPS | K182237 K193241 |
| Feb 13, 2023 | Siemens Medical Solutions USA, Inc. SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge Open, Classified |
KPS | K193248 |
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