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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)
Nov 19, 2011Philips Medical Systems
Precedence System; SYST,PRECEDENCE, 16 SLICE 3/8 Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to produc
Terminated
KPSK041218
Nov 19, 2011Philips Medical Systems
Precedence System; SYST,PRECEDENCE, 16 SLICE 5/8 Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to produc
Terminated
KPSK041218
Nov 19, 2011Philips Medical Systems
SKYLight Gamma Camera System; SKYLIGHT,AZ,9FT,5/8 Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to produ
Terminated
KPSK000908
Nov 19, 2011Philips Medical Systems
SKYLight Gamma Camera System; SKYLIGHT,AZ,9FT,3/8 Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to produ
Terminated
KPSK000908
Nov 19, 2011Philips Medical Systems
SKYLight Gamma Camera System; SKYLIGHT,AZ,8FT,5/8 Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to produ
Terminated
KPSK000908
Nov 19, 2011Philips Medical Systems
SKYLight Gamma Camera System; SKYLIGHT,AZ,8FT,3/8 Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to produ
Terminated
KPSK000908
Nov 19, 2011Philips Medical Systems
SKYLight Gamma Camera System; SKYLIGHT, 5/8",SPECT; Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to prod
Terminated
KPSK000908
Nov 19, 2011Philips Medical Systems
SKYLight Gamma Camera System; SKYLIGHT, 3/8",SPECT; Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to prod
Terminated
KPSK000908
Nov 19, 2011Philips Medical Systems
SKYLight Gamma Camera System; SKYLIGHT 8FT, 5/8" SPECT Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to
Terminated
KPSK000908
Nov 19, 2011Philips Medical Systems
SKYLight Gamma Camera System; SKYLIGHT 8FT, 3/8" SPECT Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to
Terminated
KPSK000908
Sep 13, 2011Philips Medical Systems (Cleveland) Inc
Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k) #K081135, Serial Numbers: 9201, 9202, 9203, 9204, 9205, and 9206. The recalled GEMINI TF Big Bore system unit
Terminated
KPSK081135
Aug 10, 2011Siemens Medical Solutions USA, Inc.
Symbia Radiation Therapy Pallet. Siemens Medical Solutions USA, Inc. An accessory to the Symbia T Series Emission Computed Tomography System/X-Ray Computed Tomography System.This specialty pallet i
Terminated
KPSK082506
Aug 4, 2011Philips Medical Systems
BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for in
Terminated
KPSK080927
Aug 4, 2011Philips Medical Systems
BrightView XCT Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for in
Terminated
KPSK080927
Aug 4, 2011Philips Medical Systems
BrightView X Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for inte
Terminated
KPSK062298
Aug 1, 2011Philips Medical Systems (Cleveland) Inc
GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023. The GEMINI TF Big Bore is a diagnostic imaging systems for fixed or mobile installations that combi
Terminated
KPSK081135
Aug 1, 2011Philips Medical Systems (Cleveland) Inc
Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817. Product Usag: The MX 800
Terminated
KPSK010817
Jul 22, 2011Philips Medical Systems
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 4535-602-79811; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Clevelan
Terminated
KPSK062298
Jul 22, 2011Philips Medical Systems
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 2170-3002A; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, O
Terminated
KPSK062298
Jul 22, 2011Philips Medical Systems
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number; 4535-602-79801; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Clevelan
Terminated
KPSK062298
Jul 22, 2011Philips Medical Systems
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number: 2170-3003A; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, O
Terminated
KPSK062298
Jul 22, 2011Philips Medical Systems
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 4535-602-79781; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Clevela
Terminated
KPSK062298
May 9, 2011Philips Medical Systems
Brightview XCT, 3/4" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flat pane
Terminated
KPSK080927
May 9, 2011Philips Medical Systems
Brightview XCT, 3/8" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flat pane
Terminated
KPSK080927
Mar 24, 2011Philips Medical Systems (Cleveland) Inc
Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. The Extended Brilliance Workplace (EBW) is a component o
Terminated
KPSK012009
Mar 16, 2011Philips Medical Systems (Cleveland) Inc
Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns 3001-3708, 30001-30131; Brilliance 10, M/Ns 4001-4067, 40001-40035 ; Brillianc
Terminated
KPSK012009
K033326 +2
Mar 4, 2011Philips Medical Systems
SKYLight, AZ 8 FT 3/8"; 8 FT, 5/8"; 9 FT 3/8"; and 9 FT 5/8". Philips Medical Systems Intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisot
Terminated
KPSK000908
Mar 4, 2011Philips Medical Systems
SKYLight 8 FT 3/8" SPECT; 9 FT 3/8", SPECT; 8 FT, 5/8" SPECT; and 9 FT 5/8" SPECT. Philips Medical Systems Intended to produce images depicting the anatomical distribution of single photon and positr
Terminated
KPSK000908
Nov 17, 2010Philips Medical Systems
SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535 600 66661; and 5/8" SPECT, Model number 4535 602 20381, manufactured by Philips Medical Sys
Terminated
KPSK000908
Dec 29, 2009Siemens Medical Solutions USA, Inc.
Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061. Indications for use: SPECT + CT: Perform scans and nucle
Terminated
KPSK041166
Nov 10, 2009Siemens Medical Solutions USA Inc.
Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment.
Terminated
KPSK060631
Nov 10, 2009Siemens Medical Solutions USA Inc.
Siemens Biograph mCT-S 40, model number 10248671. Medical Imaging Equipment.
Terminated
KPSK060631
Nov 10, 2009Siemens Medical Solutions USA Inc.
Siemens Biograph mCt-X, model number 10248670. Medical Imaging Equipment.
Terminated
KPSK060631
Sep 17, 2009GE Medical Systems, LLC
GE Healthcare Ventri, GE Healthcare, Waukesha, WI. Model number(s): H3000YW, H3000YY, H3000ZW, H3000YT. The intended use of the VENTRi system is to perform nuclear imaging procedures for detection an
Terminated
KPSK051855
Sep 16, 2009Phillips Nuclear Medicine
BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801,
Terminated
KPSK062298
Aug 4, 2009Siemens Medical Solutions USA, Inc.
Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061 Indications for use: SPECT +
Terminated
KPSK041166
Aug 4, 2009Siemens Medical Solutions USA, Inc.
Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061 Indications for use: SPECT + CT: Perform scans and nucle
Terminated
KPSK041166
Jul 7, 2009Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System;
Terminated
KPSK041166
Jul 7, 2009Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Part number 8717741.
Terminated
KPSK041166
Jul 6, 2009Philips Medical Systems (Cleveland) Inc
TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model # 455011002031, sold as an accessory for the GEMINI PET/CT Systems running CT software versions 3.5.x. , CT host 2.2
Terminated
KPSK052640
Jul 6, 2009Philips Medical Systems (Cleveland) Inc
TumorLoc Software Application, Software versions: 23.1.1, 20.7.13, and 20.8.15. This is an option available for purchase for use on the GEMINI GXL 16 Slice PET/CT System (contains EBW 455011002031 as
Terminated
KPSK051170
Jul 6, 2009Philips Medical Systems (Cleveland) Inc
Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. Model #455011202691 for Computed Tomography (CT); Model #455011002031 for Nuclear Medicine (NM). The "Extended Brilliance Wor
Terminated
KPSK012009
Jun 24, 2009Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81
Terminated
KPSK952109
Apr 21, 2009GE Medical Systems, LLC
GE Healthcare Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer u
Terminated
KPSK022960
Apr 21, 2009GE Medical Systems, LLC
GE Healthcare Infinia Hawkeye, Model Numbers: H3000WR, H3000WW, H3000WZ, H3000YM and H3000YS. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope trac
Terminated
KPSK022960
Apr 21, 2009GE Medical Systems, LLC
GE Healthcare Infinia, Model Numbers: ASM000886, ASM001391, ASM001333, ASM001465, ASM001473, ASM001620, ASM500016, H3000WM, H3000WT, H3000WY and SYS000041. Product is used to perform general Nuclear
Terminated
KPSK022960
Apr 10, 2009GE Medical Systems, LLC
GE Healthcare Infinia Hawkeye(R) 4, Model numbers: H3000WC H3000WD Intended use: To perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient bo
Terminated
KPSK022960
Apr 10, 2009GE Medical Systems, LLC
GE Healthcare Infinia Hawkeye(R), Model numbers: H2508PY H3000WN H3000WR H3000WW H3000WY H3000WZ H3000YM H3000YS Intended use: To perform general Nuclear Medicine imaging procedures for dete
Terminated
KPSK022960
Apr 10, 2009GE Medical Systems, LLC
GE Healthcare, Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tr
Terminated
KPSK022960
Apr 10, 2009GE Medical Systems, LLC
GE Healthcare, Hawkeye for Infinia, Model Numbers: H3000WR , H3000WW, H3000WZ , H3000YM and H3000YS. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioi
Terminated
KPSK022960

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