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)
Mar 13, 2014GE Healthcare, LLC
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detecti
Terminated
KPSK022960
Mar 13, 2014GE Healthcare, LLC
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer upta
Terminated
KPSK022960
Mar 13, 2014GE Healthcare, LLC
GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nucl
Terminated
KPSK022960
Feb 24, 2014Philips Medical Systems (Cleveland) Inc
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual d
Terminated
KPSK080927
Feb 14, 2014GE Healthcare, LLC
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomog
Terminated
KPSK081496
Feb 12, 2014Philips Medical Systems (Cleveland) Inc
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Terminated
KPSK081135
Feb 4, 2014Philips Medical Systems (Cleveland) Inc
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big
Terminated
KPSK052640
K081135
Nov 20, 2013GE Healthcare, LLC
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professio
Terminated
KPSK093514
K111445 +2
Oct 28, 2013Philips Medical Systems (Cleveland) Inc
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and i
Terminated
KPSK080927
Oct 25, 2013Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces
Terminated
KPSK052640
Oct 17, 2013GE Healthcare, LLC
GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
Terminated
KPSK081496
Aug 20, 2013GE Healthcare, LLC
The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is in
Terminated
KPSNone listed
Aug 16, 2013Siemens Medical Solutions USA, Inc.
Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomo
Terminated
KPSK082506
Aug 16, 2013Siemens Medical Solutions USA, Inc.
Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging fo
Terminated
KPSK041166
Jul 24, 2013GE Healthcare, LLC
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It incl
Terminated
KPSK121019
Jul 24, 2013GE Healthcare, LLC
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained hea
Terminated
KPSK093514
Jul 24, 2013GE Healthcare, LLC
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcar
Terminated
KPSK111445
Jul 24, 2013GE Healthcare, LLC
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and dis
Terminated
KPSK113350
Jul 24, 2013GE Healthcare, LLC
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detec
Terminated
KPSK914807
Jul 24, 2013GE Healthcare, LLC
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer upt
Terminated
KPSK953801
Jul 24, 2013GE Healthcare, LLC
GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear
Terminated
KPSK022960
K052434 +1
Jun 5, 2013Philips Medical Systems (Cleveland) Inc
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging ac
Terminated
KPSK062298
Apr 24, 2013GE Healthcare, LLC
Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.
Terminated
KPSK051855
K080124
Apr 10, 2013GE Healthcare, LLC
GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, al
Terminated
KPSK022960
K052434 +1
Apr 1, 2013Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Terminated
KPSK052640
Feb 28, 2013Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT. Diagnostic imaging system
Terminated
KPSK052640
Feb 26, 2013Philips Medical Systems (Cleveland) Inc
Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile inst
Terminated
KPSK081135
Feb 26, 2013Philips Medical Systems (Cleveland) Inc
Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT)
Terminated
KPSK052640
Dec 21, 2012Philips Medical Systems (Cleveland) Inc
Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed T
Terminated
KPSK961464
Oct 23, 2012GE Healthcare, LLC
GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases a
Terminated
KPSK093514
K111445
Aug 22, 2012Philips Medical Systems (Cleveland) Inc
Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a diagn
Terminated
KPSK051170
K052640 +1
May 30, 2012Siemens Medical Solutions USA, Inc.
e.cam Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomography Systems is used for all common nuclear medicine procedures.
Terminated
KPSK952109
May 30, 2012Siemens Medical Solutions USA, Inc.
Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symbia E system is a high performance dual detector variable angle system with flexible patient positioning for pl
Terminated
KPSK072567
Apr 5, 2012Philips Medical Systems (Cleveland) Inc
GEMINI TF 16, 64 & Big Bore Computed Tomography X-Ray Systems, M/N 882470, 882471 & 882476, Distributed by: Philips Medical System, Cleveland, OH Product Usage: The Computed Tomography X-Ray System
Terminated
KPSK052640
K081135
Apr 5, 2012Philips Medical Systems (Cleveland) Inc
GEMINI GXL 6, 10 & 16 Computed Tomography X-Ray Systems, M/N 882390, 882400 & 882410, Distributed by: Philips Medical System, Cleveland, OH Product Usage: The Computed Tomography X-Ray Systems are
Terminated
KPSK051170
Mar 30, 2012Philips Medical Systems (Cleveland) Inc
IntelliSpace Portal, M/N 881001, IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin- client applications server that delivers full diagnostic viewing and clinical applications to the e
Terminated
KPSK060937
Mar 21, 2012Spectrum Dynamics
D-SPECT Cardiac Scanner System -- COMMON/USUAL NAME: Emission Computed Tomography System --- SPECTRUM DYNAMICS --- Spectrum Dynamics (Israel) Ltd. 22 Bareket St. North Industrial Park, P.O. Box 3033,
Terminated
KPSK072468
Mar 16, 2012Philips Medical Systems (Cleveland) Inc
The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System. The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System that
Terminated
KPSK000908
Feb 27, 2012GE Healthcare, LLC
GE Discovery NM 630 The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in
Terminated
KPSK111445
Feb 27, 2012GE Healthcare, LLC
GE Discovery NM/CT 670 The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases a
Terminated
KPSK093514
Feb 17, 2012Philips Medical Systems (Cleveland) Inc
TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model #459800111661. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (
Terminated
KPSK052640
Feb 10, 2012Philips Medical Systems (Cleveland) Inc
Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. Used to do nuclear medicine diagnostic imaging of various body organs.
Terminated
KPSK964712
Feb 2, 2012Philips Medical Systems (Cleveland) Inc
GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System, Philips Medical Systems, Cleveland, OH The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emis
Terminated
KPSK052640
Jan 18, 2012Philips Medical Systems (Cleveland) Inc
GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model #882471 Philips Medical Systems, Hig
Terminated
KPSK052640
Jan 11, 2012Philips Medical Systems
SKYLight Imaging Systems, Model 882050; Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation
Terminated
KPSK000908
Dec 1, 2011Philips Medical Systems (Cleveland) Inc
Philips GEMINI TF 64 Diagnostic CT X-ray/PET Imaging System, Catalog/Model #882471, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The G
Terminated
KPSK081135
Dec 1, 2011Philips Medical Systems (Cleveland) Inc
Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6, and TF 64
Terminated
KPSK081135
Nov 23, 2011Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same
Terminated
KPSK082506
Nov 19, 2011Philips Medical Systems
Precedence System; SYST,PRECEDENCE, 6 SLICE 5/8 Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to product
Terminated
KPSK041218
Nov 19, 2011Philips Medical Systems
Precedence System; SYST,PRECEDENCE, 6 SLICE 3/8 Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to product
Terminated
KPSK041218

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