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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)
Mar 16, 2017Philips Medical Systems (Cleveland) Inc
882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-
Terminated
KPSK062298
K080927
Mar 16, 2017Philips Medical Systems (Cleveland) Inc
882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar stati
Terminated
KPSK062298
K080927
Feb 28, 2017Siemens Medical Solutions USA Inc.
Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distri
Terminated
KPSK141971
Feb 28, 2017Siemens Medical Solutions USA Inc.
Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution
Terminated
KPSK141971
Feb 28, 2017Siemens Medical Solutions USA Inc.
Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution of in
Terminated
KPSK141971
Feb 28, 2017Siemens Medical Solutions USA Inc.
Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution of in
Terminated
KPSK141971
Jan 10, 2017Siemens Medical Solutions USA Inc.
Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners th
Terminated
KPSK151486
Jan 10, 2017Siemens Medical Solutions USA Inc.
Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners
Terminated
KPSK151486
Jan 10, 2017Siemens Medical Solutions USA Inc.
BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that
Terminated
KPSK151486
Jan 10, 2017Siemens Medical Solutions USA Inc.
Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scan
Terminated
KPSK151486
Jan 10, 2017Siemens Medical Solutions USA Inc.
Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanne
Terminated
KPSK151486
Jan 10, 2017Siemens Medical Solutions USA Inc.
Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that pro
Terminated
KPSK151486
Jan 10, 2017Siemens Medical Solutions USA Inc.
Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that
Terminated
KPSK151486
Jan 10, 2017Siemens Medical Solutions USA Inc.
Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that
Terminated
KPSK151486
Jan 10, 2017Siemens Medical Solutions USA Inc.
Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that pro
Terminated
KPSK151486
Jan 10, 2017Siemens Medical Solutions USA Inc.
Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that
Terminated
KPSK151486
Jan 10, 2017Siemens Medical Solutions USA Inc.
Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that
Terminated
KPSK151486
Dec 23, 2016Philips Medical Systems (Cleveland) Inc
BrightView X upgraded to XCT 882454
Terminated
KPSK080927
Dec 23, 2016Philips Medical Systems (Cleveland) Inc
BrightView XCT
Terminated
KPSK080927
Oct 6, 2016Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
Terminated
KPSNone listed
Jun 21, 2016Siemens Medical Solutions USA Inc.
Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that pro
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registratio
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide reg
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide reg
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide re
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide r
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that p
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provi
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that prov
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regi
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registra
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registra
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provid
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provi
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide
Terminated
KPSK141971
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr
Terminated
KPSK141971

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