510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Biograph True Pet/CT Family Software

K141971510(k) SpecialCleared Sep 12, 201453-day reviewClass II21 CFR 892.1200Recalls 37

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Medical Solutions USA, Inc. · KPS System, Tomography, Computed, Emission

Cleared on Sep 12, 2014 as substantially equivalent to K123737 (Siemens Medical Solutions USA, Inc., 2013) after a 53-day review. Its family tree reaches back 12 generations to 2000. It has been recalled 37 times.

Decided
Sep 12, 2014
Review
53 days
Class
Class II
Product code
KPS
Recalls
37
Predicates
1

Its longest line of descent runs back 12 generations to K002715 (2000). 18 ancestors in all, the oldest K843696 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 2 other ancestors2001: 1 other ancestor1998: 1 other ancestor1985: 2 other ancestorsReference device: K083852 · Biograph 16 True Point Systems · Siemens Medical Solutions USA, Inc. · 2009K002715 · Ecat Pet Scanner · Cti Pet Systems, Inc. · 2000 · recalledK013504 · Modification to: Ecat Lso Pet/CT Scanner · Cti Pet Systems, Inc. · 2001 · recalledK023518 · Ecat Lso Pet/CT 16 · Cti Pet Systems, Inc. · 2002 · recalledK033431 · Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez · Cti Pet Systems, Inc. · 2003 · recalledK042467 · Lso Pet/CT Hirez 64 · Cti Pet Systems, Inc. · 2004 · recalledK050509 · Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I · Cti Pet Systems, Inc. · 2005×2: 2 generations cleared close together, K060060 (2006), K060631 (2006) K081453 · Biograph HD Family · Siemens Medical Solutions USA, Inc. · 2008K101550 · Biograph MCT Family · Siemens Medical Solutions USA, Inc. · 2010K113448 · Biograph MCT Family · Siemens Medical Solutions USA, Inc. · 2011K123737 · Biograph MCT Family · Siemens Medical Solutions USA, Inc. · 2013 · recalled1985199019952000200520102015
Other ancestors, by generation 6 generations back: 1 other ancestor7 generations back: 1 other ancestor8 generations back: 2 other ancestors9 generations back: 2 other ancestors K123737 · Biograph MCT Family · Siemens Medical Solutions USA, Inc. · 2013 · recalledK113448 · Biograph MCT Family · Siemens Medical Solutions USA, Inc. · 2011K101550 · Biograph MCT Family · Siemens Medical Solutions USA, Inc. · 2010K081453 · Biograph HD Family · Siemens Medical Solutions USA, Inc. · 2008K060631 · Biograph 64 and Biograph 40 · Siemens Medical Solutions USA, Inc. · 2006 · recalledK060060 · Biograph 6 · Siemens Medical Solutions USA, Inc. · 2006K050509 · Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I · Cti Pet Systems, Inc. · 2005K042467 · Lso Pet/CT Hirez 64 · Cti Pet Systems, Inc. · 2004 · recalledK033431 · Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez · Cti Pet Systems, Inc. · 2003 · recalledK023518 · Ecat Lso Pet/CT 16 · Cti Pet Systems, Inc. · 2002 · recalledK013504 · Modification to: Ecat Lso Pet/CT Scanner · Cti Pet Systems, Inc. · 2001 · recalledK002715 · Ecat Pet Scanner · Cti Pet Systems, Inc. · 2000 · recalled−10−50
  1. Root · 12 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
  2. 8 generations between
  3. 3 generations backK101550 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2010
  4. 2 generations backK113448 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2011
  5. 1 generation backK123737 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2013 · Recalled
  6. This deviceK141971 Biograph True Pet/CT Family SoftwareSiemens Medical Solutions USA, Inc. · 2014
Show all 12 generations
  1. Root · 12 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
  2. 11 generations backK013504 Modification to: Ecat Lso Pet/CT ScannerCti Pet Systems, Inc. · 2001 · Recalled
  3. 10 generations backK023518 Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002 · Recalled
  4. 9 generations backK033431 Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc. · 2003 · Recalled
  5. 8 generations backK042467 Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · Recalled
  6. 7 generations backK050509 Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005
  7. 6 generations backK060060 Biograph 6Siemens Medical Solutions USA, Inc. · 2006
  8. 5 generations backK060631 Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · Recalled
  9. 4 generations backK081453 Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008
  10. 3 generations backK101550 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2010
  11. 2 generations backK113448 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2011
  12. 1 generation backK123737 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2013 · Recalled
  13. This deviceK141971 Biograph True Pet/CT Family SoftwareSiemens Medical Solutions USA, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K002715Ecat Pet ScannerCti Pet Systems, Inc.20002
−11K013504Modification to: Ecat Lso Pet/CT ScannerCti Pet Systems, Inc.20012
−10K023518Ecat Lso Pet/CT 16Cti Pet Systems, Inc.20021
−9K033431Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc.20031
−8K042467Lso Pet/CT Hirez 64Cti Pet Systems, Inc.20041
−7K050509Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc.2005—
−6K060060Biograph 6Siemens Medical Solutions USA, Inc.2006—
−5K060631Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc.20063
−4K081453Biograph HD FamilySiemens Medical Solutions USA, Inc.2008—
−3K101550Biograph MCT FamilySiemens Medical Solutions USA, Inc.2010—
−2K113448Biograph MCT FamilySiemens Medical Solutions USA, Inc.2011—
−1K123737Biograph MCT FamilySiemens Medical Solutions USA, Inc.201317
0 (this device)K141971Biograph True Pet/CT Family SoftwareSiemens Medical Solutions USA, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198520
199810
200110
200420
FIG. 1 — Lineage of K141971, 2000–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KPS device

  1. #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K123737Biograph MCT Family
Summary page 5
…redicate Device Manufacturer 510(k) Number Primary Predicate Biograph mCT Family Siemens Medical K123737 PET/CT scanner software Solutions USA, Inc Reference Predicate Biograph TruePoint S…
Siemens Medical Solutions USA, Inc.201317
†K083852Biograph 16 True Point SystemsSiemens Medical Solutions USA, Inc.2009—

Also cleared against K123737: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 20, 2017Class IIZ-1424-2017Labeling Change ControlThe mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
Feb 20, 2017Class IIZ-1425-2017Labeling Change ControlThe mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
Feb 20, 2017Class IIZ-1423-2017Labeling Change ControlThe mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
Feb 20, 2017Class IIZ-1422-2017Labeling Change ControlThe mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
Apr 22, 2016Class IIZ-2035-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2006-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2032-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2037-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2007-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2027-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2025-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2024-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2030-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2008-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2015-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2018-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2014-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2031-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2033-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2012-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2026-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2010-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2029-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2016-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2011-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2036-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2019-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2020-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2022-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2034-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2023-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2017-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2021-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2005-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2013-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2009-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Apr 22, 2016Class IIZ-2028-2016Nonconforming Material/ComponentSiemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

The 5 latest of 37 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
  • 9 of the 18 ancestors have a recall of any class.
  • 1 other device also cites its predicate K123737.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · KPS

12in 2025

2007: 82008: 172009: 92010: 32011: 72012: 62013: 112014: 112015: 32016: 112017: 112018: 132019: 32020: 122021: 152022: 52023: 122024: 112025: 122026 (partial year): 6
2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007: 38 days median2008: 25 days median2009: 42 days median2010: 91 days median2011: 28 days median2012: 94 days median2013: 84 days median2014: 92 days median2015: 112 days median2016: 65 days median2017: 104 days median2018: 59 days median2019: 60 days median2020: 72 days median2021: 66 days median2022: 60 days median2023: 63 days median2024: 59 days median2025: 65 days median2026 (partial year): 67 days median
2007high 112 (2015) · low 25 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPS

16in 2025

2007: 222008: 162009: 142010: 42011: 342012: 132013: 132014: 182015: 52016: 162017: 112018: 12, 3 Class I2019: 5, 5 Class I2020: 82021: 42022: 8, 6 Class I2023: 6, 3 Class I2024: 152025: 162026 (partial year): 6
2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007: 382008: 112009: 152010: 442011: 562012: 342013: 2402014: 332015: 242016: 102017: 312018: 262019: 1052020: 222021: 102022: 152023: 222024: 232025: 36
2007high 240 (2013) · low 10 (2016)2025

MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078382238
200817251611
20099421415
2010391444
20117283456
20126941334
2013118413240
201411921833
20153112524
201611651610
2017111041131
2018135912 (3)26
20193605 (5)105
20201272822
20211566410
20225608 (6)15
202312636 (3)22
202411591523
202512651636
20266676—

What is it indicated for?

The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET…

Read the full statement (206 words)

The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.

The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.

These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Indications for use as stated in the FDA summary.

Also cleared against K123737

1 other device cites the same predicate.

  • K151486Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc. · 201511 recalls

More from Siemens Medical Solutions USA, Inc.

798 FDA decisions under this applicant name. See the company

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  • K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc. · 2026
  • P140011/S009MAMMOMAT B.brilliant with Tomosynthesis OptionSiemens Medical Solutions USA, Inc. · 2026
  • K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · 2026

Recent decisions in KPS

The KPS category page

  • K261305Micsi-PetMicrostructure Imaging, Inc. · 2026
  • K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd. · 2026
  • K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia…Siemens Medical Solutions USA, Inc. · 2026
  • K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI…Shanghai United Imaging Healthcare Co., Ltd. · 2026
  • K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI…Shanghai United Imaging Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K141971 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141971: Biograph True Pet/CT Family Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141971

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026