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) |
|---|---|---|---|
| Feb 13, 2023 | Siemens Medical Solutions USA, Inc. SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile Open, Classified |
KPS | K193248 |
| Feb 13, 2023 | Siemens Medical Solutions USA, Inc. SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission Open, Classified |
KPS | K193178 |
| 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 |
| Oct 13, 2022 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI 550 Open, Classified |
KPS | K182237 K193241 |
| Mar 11, 2022 | Siemens Medical Solutions USA, Inc. Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems Terminated |
KPS | K200474 |
| Aug 2, 2021 | Shanghai United Imaging Healthcare Co., Ltd. uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and t Open, Classified |
KPS | K182237 K193241 |
| Aug 2, 2021 | Shanghai United Imaging Healthcare Co., Ltd. uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment Open, Classified |
KPS | K182237 K193241 |
| May 11, 2021 | GE Healthcare, LLC NM/CT 870 DR Nuclear Medicine / CT Scanners Open, Classified |
KPS | K093514 |
| May 11, 2021 | GE Healthcare, LLC NM/CT 860 Nuclear Medicine / CT Scanners Open, Classified |
KPS | K173816 |
| May 11, 2021 | GE Healthcare, LLC NM/CT 850 Nuclear Medicine / CT Scanners Open, Classified |
KPS | K173816 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64
System Number: 882471
Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to Open, Classified |
KPS | K052640 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16
System Number: 882470
Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists Open, Classified |
KPS | K051170 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT
System Number: 882438
Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and ra Open, Classified |
KPS | K052640 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice
System Number: 882410
Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiol Open, Classified |
KPS | K051170 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
882476 - Gemini TF Big Bore PET/CT Open, Classified |
KPS | K081135 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
882446 - Vereos PET/CT Open, Classified |
KPS | K123599 |
| Dec 10, 2020 | GE Healthcare, LLC Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. Terminated |
KPS | K121019 |
| Dec 10, 2020 | GE Healthcare, LLC Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately traine Terminated |
KPS | K093514 |
| Dec 10, 2020 | GE Healthcare, LLC Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detect Terminated |
KPS | K111445 |
| Dec 10, 2020 | GE Healthcare, LLC GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. Terminated |
KPS | K153402 |
| Dec 10, 2020 | GE Healthcare, LLC GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. Terminated |
KPS | K173816 |
| Dec 10, 2020 | GE Healthcare, LLC GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. Terminated |
KPS | K173816 |
| Nov 11, 2020 | Canon Medical System, USA, INC. Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A Terminated |
KPS | K203314 |
| Aug 14, 2020 | GE Healthcare, LLC NM/CT 870 DR
Model # H3100AS Terminated |
KPS | K093514 |
| Aug 14, 2020 | GE Healthcare, LLC Discovery NM670 Pro
Model # H3100XB Terminated |
KPS | K093514 |
| Aug 14, 2020 | GE Healthcare, LLC Discovery 670 DR
Model # H3100BT Terminated |
KPS | K093514 |
| Aug 14, 2020 | GE Healthcare, LLC NM 830
Model # H3910AC Terminated |
KPS | K111445 |
| Aug 14, 2020 | GE Healthcare, LLC Discovery NM 630
Model # H3101RH Terminated |
KPS | K111445 |
| Aug 14, 2020 | GE Healthcare, LLC NM/CT 870 CZT
Model # H3906CW Terminated |
KPS | K153402 |
| Aug 14, 2020 | GE Healthcare, LLC NM/CT 860, SPECT/CT Terminated |
KPS | K173816 |
| Aug 14, 2020 | GE Healthcare, LLC NM/CT 850
Model Number: H3907AD Terminated |
KPS | K173816 |
| Aug 14, 2020 | Siemens Medical Solutions USA, Inc. Symbia S-Series and Symbia T-Series - Product Usage:
Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: plana Terminated |
KPS | K200474 |
| Aug 13, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, r Terminated |
KPS | K182938 |
| Aug 5, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in th Open, Classified |
KPS | K182237 |
| Jun 3, 2020 | GE Healthcare, LLC System, Tomography Computed Emmission Open, Classified |
KPS | K080124 |
| Jun 3, 2020 | GE Healthcare, LLC System, Tomography Computed Emmission Open, Classified |
KPS | K051855 |
| Mar 26, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to Terminated |
KPS | K182237 |
| Nov 1, 2019 | Philips Medical Systems (Cleveland) Inc Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn Terminated |
KPS | K033254 |
| Nov 1, 2019 | Philips Medical Systems (Cleveland) Inc Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn Terminated |
KPS | K982911 |
| Nov 1, 2019 | Philips Medical Systems (Cleveland) Inc Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn Terminated |
KPS | K033254 |
| Nov 1, 2019 | Philips Medical Systems (Cleveland) Inc Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn Terminated |
KPS | K033254 |
| Nov 1, 2019 | Philips Medical Systems (Cleveland) Inc Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn Terminated |
KPS | K982911 |
| Aug 26, 2019 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended Terminated |
KPS | K182237 |
| Jun 19, 2019 | GE Healthcare, LLC Discovery Ml DR
Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission
Tomography (PET) imaging and localization of emission activity in patient anat Open, Classified |
KPS | K133657 |
| Jun 19, 2019 | GE Healthcare, LLC Discovery Ml
Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatom Open, Classified |
KPS | K161574 |
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