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) |
|---|---|---|---|
| Mar 13, 2014 | GE 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 |
KPS | K022960 |
| Mar 13, 2014 | GE 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 |
KPS | K022960 |
| Mar 13, 2014 | GE 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 |
KPS | K022960 |
| Feb 24, 2014 | Philips 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 |
KPS | K080927 |
| Feb 14, 2014 | GE 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 |
KPS | K081496 |
| Feb 12, 2014 | Philips Medical Systems (Cleveland) Inc GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH Terminated |
KPS | K081135 |
| Feb 4, 2014 | Philips 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 |
KPS | K052640 K081135 |
| Nov 20, 2013 | GE 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 |
KPS | K093514 K111445 +2 |
| Oct 28, 2013 | Philips 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 |
KPS | K080927 |
| Oct 25, 2013 | Philips 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 |
KPS | K052640 |
| Oct 17, 2013 | GE Healthcare, LLC GE PET Discovery 610, PET Discovery 710.
Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging. Terminated |
KPS | K081496 |
| Aug 20, 2013 | GE 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 |
KPS | None listed |
| Aug 16, 2013 | Siemens 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 |
KPS | K082506 |
| Aug 16, 2013 | Siemens 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 |
KPS | K041166 |
| Jul 24, 2013 | GE 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 |
KPS | K121019 |
| Jul 24, 2013 | GE 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 |
KPS | K093514 |
| Jul 24, 2013 | GE 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 |
KPS | K111445 |
| Jul 24, 2013 | GE 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 |
KPS | K113350 |
| Jul 24, 2013 | GE 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 |
KPS | K914807 |
| Jul 24, 2013 | GE 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 |
KPS | K953801 |
| Jul 24, 2013 | GE 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 |
KPS | K022960 K052434 +1 |
| Jun 5, 2013 | Philips 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 |
KPS | K062298 |
| Apr 24, 2013 | GE 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 |
KPS | K051855 K080124 |
| Apr 10, 2013 | GE 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 |
KPS | K022960 K052434 +1 |
| Apr 1, 2013 | Philips 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 |
KPS | K052640 |
| Feb 28, 2013 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT. Diagnostic imaging system Terminated |
KPS | K052640 |
| Feb 26, 2013 | Philips 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 |
KPS | K081135 |
| Feb 26, 2013 | Philips 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 |
KPS | K052640 |
| Dec 21, 2012 | Philips 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 |
KPS | K961464 |
| Oct 23, 2012 | GE 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 |
KPS | K093514 K111445 |
| Aug 22, 2012 | Philips 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 |
KPS | K051170 K052640 +1 |
| May 30, 2012 | Siemens 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 |
KPS | K952109 |
| May 30, 2012 | Siemens 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 |
KPS | K072567 |
| Apr 5, 2012 | Philips 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 |
KPS | K052640 K081135 |
| Apr 5, 2012 | Philips 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 |
KPS | K051170 |
| Mar 30, 2012 | Philips 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 |
KPS | K060937 |
| Mar 21, 2012 | Spectrum 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 |
KPS | K072468 |
| Mar 16, 2012 | Philips 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 |
KPS | K000908 |
| Feb 27, 2012 | GE 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 |
KPS | K111445 |
| Feb 27, 2012 | GE 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 |
KPS | K093514 |
| Feb 17, 2012 | Philips 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 |
KPS | K052640 |
| Feb 10, 2012 | Philips 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 |
KPS | K964712 |
| Feb 2, 2012 | Philips 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 |
KPS | K052640 |
| Jan 18, 2012 | Philips 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 |
KPS | K052640 |
| Jan 11, 2012 | Philips 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 |
KPS | K000908 |
| Dec 1, 2011 | Philips 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 |
KPS | K081135 |
| Dec 1, 2011 | Philips 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 |
KPS | K081135 |
| Nov 23, 2011 | Siemens 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 |
KPS | K082506 |
| Nov 19, 2011 | Philips 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 |
KPS | K041218 |
| Nov 19, 2011 | Philips 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 |
KPS | K041218 |
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