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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)
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK052640
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK052640
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK052640
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK051460
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK052640
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK052640
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK051170
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK041218
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK041218
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK033254
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK041955
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK964712
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
KPSK982911
May 28, 2015Philips Medical Systems (Cleveland) Inc
Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines
Terminated
KPSK103483
May 12, 2015Philips Medical Systems (Cleveland) Inc
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
Terminated
KPSK922080
K952684
Mar 19, 2015Siemens Medical Solutions USA, Inc.
E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographi
Terminated
KPSK952109
Mar 19, 2015Siemens Medical Solutions USA, Inc.
Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic
Terminated
KPSK072567
Mar 13, 2015GE Healthcare
GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging proce
Terminated
KPSK953801
Feb 10, 2015Siemens Medical Solutions USA, Inc.
The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders.
Terminated
KPSK082506
Feb 10, 2015Siemens Medical Solutions USA, Inc.
The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders.
Terminated
KPSK041166
Jan 26, 2015Philips Medical Systems (Cleveland) Inc
BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging
Terminated
KPSK080927
Jan 13, 2015Siemens Medical Solutions USA, Inc.
Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.
Terminated
KPSK082506
Jan 6, 2015Siemens Medical Solutions USA, Inc.
e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomograp
Terminated
KPSK952109
K982387 +1
Jan 6, 2015Siemens Medical Solutions USA, Inc.
The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPECT
Terminated
KPSK131634
Jan 6, 2015Siemens Medical Solutions USA, Inc.
The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and or
Terminated
KPSK131634
Jan 6, 2015Siemens Medical Solutions USA, Inc.
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and or
Terminated
KPSK131634
Dec 16, 2014Siemens Medical Solutions USA Inc.
Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis
Terminated
KPSK123737
Dec 16, 2014Siemens Medical Solutions USA Inc.
Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis
Terminated
KPSK123737
Dec 16, 2014Siemens Medical Solutions USA Inc.
Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registrat
Terminated
KPSK123737
Dec 16, 2014Siemens Medical Solutions USA Inc.
Biograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide reg
Terminated
KPSK123737
Dec 16, 2014Siemens Medical Solutions USA Inc.
Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide r
Terminated
KPSK123737
Dec 16, 2014GE 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
KPSK022960
K052434 +1
Dec 16, 2014GE 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
KPSK022960
K052434 +1
Dec 16, 2014GE 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
KPSK022960
K052434 +1
Dec 16, 2014GE 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
KPSK022960
K052434 +1
Dec 16, 2014GE 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
KPSK022960
K052434 +1
Dec 16, 2014GE 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
KPSK022960
K052434 +1
Dec 12, 2014Philips Medical Systems, Inc.
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.
Terminated
KPSK080927
Dec 1, 2014Philips Medical Systems (Cleveland) Inc
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
Terminated
KPSK062298
K080927
Oct 22, 2014Siemens Medical Solutions USA, Inc.
e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
Terminated
KPSK952109
Oct 22, 2014Siemens Medical Solutions USA, Inc.
Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.
Terminated
KPSK082506
Sep 29, 2014Siemens Medical Solutions USA, Inc.
The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quali
Terminated
KPSK082506
K131634
Sep 29, 2014Siemens Medical Solutions USA, Inc.
The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The
Terminated
KPSK082506
K131634
Jul 11, 2014Siemens Medical Solutions USA, Inc.
Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body
Terminated
KPSK131634
Jul 11, 2014Siemens Medical Solutions USA, Inc.
e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body ima
Terminated
KPSK131634
Jul 10, 2014Philips Medical Systems (Cleveland) Inc
GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) a
Terminated
KPSK052640
K081135
Jul 2, 2014Philips Medical Systems (Cleveland) Inc
BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical De
Terminated
KPSK080927
Jun 2, 2014Philips Medical Systems (Cleveland) Inc
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imagin
Terminated
KPSK012009
K033326 +2
Apr 26, 2014Philips Medical Systems (Cleveland) Inc
Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution o
Terminated
KPSK922080
K952684
Apr 16, 2014Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Terminated
KPSK033326

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