510(k) · Cleared
Recalled · Class II · 2023Biograph Horizon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solution USA, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Feb 12, 2020 as substantially equivalent to K170904 (Siemens Medical Solutions USA, Inc., 2017) after an 86-day review. Its family tree reaches back 15 generations to 2000. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 12, 2020
- Review
- 86 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 15 generations to K002715 (2000). 21 ancestors in all, the oldest K843696 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 11 generations between
- 3 generations backK151486 Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- 2 generations backK152880 Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- 1 generation backK170904 Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc. · 2017 · Recalled
- This deviceK193178 Biograph HorizonSiemens Medical Solution USA, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK253844 AnyScan 3.0 NM Scanner FamilyMediso Medical Imaging Systems, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK222895 DynamicIQGE Medical Systems SCS · 2022
Show all 15 generations
- Root · 15 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 14 generations backK013504 Modification to: Ecat Lso Pet/CT ScannerCti Pet Systems, Inc. · 2001 · Recalled
- 13 generations backK023518 Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002 · Recalled
- 12 generations backK033431 Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc. · 2003 · Recalled
- 11 generations backK042467 Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · Recalled
- 10 generations backK050509 Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005
- 9 generations backK060060 Biograph 6Siemens Medical Solutions USA, Inc. · 2006
- 8 generations backK060631 Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- 7 generations backK081453 Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008
- 6 generations backK101550 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2010
- 5 generations backK113448 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2011
- 4 generations backK123737 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 3 generations backK151486 Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- 2 generations backK152880 Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- 1 generation backK170904 Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc. · 2017 · Recalled
- This deviceK193178 Biograph HorizonSiemens Medical Solution USA, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K002715 | Ecat Pet Scanner | Cti Pet Systems, Inc. | 2000 | 2 |
| −14 | K013504 | Modification to: Ecat Lso Pet/CT Scanner | Cti Pet Systems, Inc. | 2001 | 2 |
| −13 | K023518 | Ecat Lso Pet/CT 16 | Cti Pet Systems, Inc. | 2002 | 1 |
| −12 | K033431 | Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez | Cti Pet Systems, Inc. | 2003 | 1 |
| −11 | K042467 | Lso Pet/CT Hirez 64 | Cti Pet Systems, Inc. | 2004 | 1 |
| −10 | K050509 | Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I | Cti Pet Systems, Inc. | 2005 | — |
| −9 | K060060 | Biograph 6 | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −8 | K060631 | Biograph 64 and Biograph 40 | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −7 | K081453 | Biograph HD Family | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −6 | K101550 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2010 | — |
| −5 | K113448 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2011 | — |
| −4 | K123737 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2013 | 17 |
| −3 | K151486 | Biograph mCT and mCT Flow PET/CT Scanners | Siemens Medical Solutions USA, Inc. | 2015 | 11 |
| −2 | K152880 | Biograph Horizon PET/CT | Siemens Medical Solutions USA, Inc. | 2016 | 1 |
| −1 | K170904 | Biograph Horizon PET/CT | Siemens Medical Solutions USA, Inc. | 2017 | 4 |
| 0 (this device) | K193178 | Biograph Horizon | Siemens Medical Solution USA, Inc. | 2020 | — |
| +1 | K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. | 2025 | — |
| +1 | K222895 | DynamicIQ | GE Medical Systems SCS | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
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 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170904 | Biograph Horizon PET/CTSummary page 5…Manufacturer: Siemens Medical Solutions USA, Inc. Product Code: KPS and JAK Device Class: Class II 510(k) Number: K170904 Reference Devices: Device Name and 510(k) Biograph mCT PET/CT systems K173578 numbers: Biograph V… | 2017 |
| † | K173578 | Biograph mCT Family of PET/CT Systems | 2017 |
| † | K190900 | Biograph Vision | 2019 |
| † | K183548 | SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 | 2019 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2023 | Class II | Z-1134-2023 | Process control | This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- 12 of the 21 ancestors have a recall of any class.
- Of its descendants, K253844 (Mediso Medical Imaging Systems, Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
The Siemens Biograph Horizon PET/CT 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 (257 words)
The Siemens Biograph Horizon PET/CT 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 re staging 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.
This CT system can be used for low dose lung cancer screening in high risk populations.*
* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193178: Biograph Horizon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193178
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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