ClearanceBrief
Panels › Radiology › Product code KPS · Class 2

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)
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Top companies in KPS

DateFirm and productCodeLinked 510(k)
Feb 13, 2023Siemens 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
KPSK193248
Feb 13, 2023Siemens Medical Solutions USA, Inc.
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Open, Classified
KPSK193178
Feb 8, 2023GE 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
KPSK173816
Feb 8, 2023GE 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
KPSK153402
Feb 8, 2023GE 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
KPSK121019
Feb 8, 2023GE 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
KPSK113350
Feb 8, 2023GE 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
KPSK111445
Feb 8, 2023GE 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
KPSK093514
Oct 13, 2022Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Open, Classified
KPSK182237
K193241
Mar 11, 2022Siemens Medical Solutions USA, Inc.
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Terminated
KPSK200474
Aug 2, 2021Shanghai 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
KPSK182237
K193241
Aug 2, 2021Shanghai 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
KPSK182237
K193241
May 11, 2021GE Healthcare, LLC
NM/CT 870 DR Nuclear Medicine / CT Scanners
Open, Classified
KPSK093514
May 11, 2021GE Healthcare, LLC
NM/CT 860 Nuclear Medicine / CT Scanners
Open, Classified
KPSK173816
May 11, 2021GE Healthcare, LLC
NM/CT 850 Nuclear Medicine / CT Scanners
Open, Classified
KPSK173816
May 1, 2021Philips 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
KPSK052640
May 1, 2021Philips 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
KPSK051170
May 1, 2021Philips 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
KPSK052640
May 1, 2021Philips 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
KPSK051170
May 1, 2021Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT
Open, Classified
KPSK081135
May 1, 2021Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
Open, Classified
KPSK123599
Dec 10, 2020GE 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
KPSK121019
Dec 10, 2020GE 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
KPSK093514
Dec 10, 2020GE 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
KPSK111445
Dec 10, 2020GE 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
KPSK153402
Dec 10, 2020GE 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
KPSK173816
Dec 10, 2020GE 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
KPSK173816
Nov 11, 2020Canon Medical System, USA, INC.
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Terminated
KPSK203314
Aug 14, 2020GE Healthcare, LLC
NM/CT 870 DR Model # H3100AS
Terminated
KPSK093514
Aug 14, 2020GE Healthcare, LLC
Discovery NM670 Pro Model # H3100XB
Terminated
KPSK093514
Aug 14, 2020GE Healthcare, LLC
Discovery 670 DR Model # H3100BT
Terminated
KPSK093514
Aug 14, 2020GE Healthcare, LLC
NM 830 Model # H3910AC
Terminated
KPSK111445
Aug 14, 2020GE Healthcare, LLC
Discovery NM 630 Model # H3101RH
Terminated
KPSK111445
Aug 14, 2020GE Healthcare, LLC
NM/CT 870 CZT Model # H3906CW
Terminated
KPSK153402
Aug 14, 2020GE Healthcare, LLC
NM/CT 860, SPECT/CT
Terminated
KPSK173816
Aug 14, 2020GE Healthcare, LLC
NM/CT 850 Model Number: H3907AD
Terminated
KPSK173816
Aug 14, 2020Siemens 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
KPSK200474
Aug 13, 2020Shanghai 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
KPSK182938
Aug 5, 2020Shanghai 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
KPSK182237
Jun 3, 2020GE Healthcare, LLC
System, Tomography Computed Emmission
Open, Classified
KPSK080124
Jun 3, 2020GE Healthcare, LLC
System, Tomography Computed Emmission
Open, Classified
KPSK051855
Mar 26, 2020Shanghai 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
KPSK182237
Nov 1, 2019Philips 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
KPSK033254
Nov 1, 2019Philips 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
KPSK982911
Nov 1, 2019Philips 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
KPSK033254
Nov 1, 2019Philips 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
KPSK033254
Nov 1, 2019Philips 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
KPSK982911
Aug 26, 2019Shanghai 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
KPSK182237
Jun 19, 2019GE 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
KPSK133657
Jun 19, 2019GE 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
KPSK161574

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