ClearanceBrief
510(k) K141971 ยท KPS System, Tomography, Computed, Emission

BIOGRAPH TRUE PET/CT FAMILY SOFTWARE

ApplicantSiemens Medical Solutions USA, Inc., Knoxville TN, US
DecisionSubstantially Equivalent, Sep 12, 2014
ReceivedJul 21, 2014
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K141971

DateFirm and productCodeLinked 510(k)
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
Jun 21, 2016Siemens Medical Solutions USA Inc.
Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registratio
Terminated
KPSNone listed
Jun 21, 2016Siemens Medical Solutions USA Inc.
Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis
Terminated
KPSNone listed
Jun 21, 2016Siemens Medical Solutions USA Inc.
BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registrat
Terminated
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
KPSNone listed
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
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
KPSNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.