Biograph Horizon
K193178Siemens Medical Solution USA, Inc. · cleared 2020-02-12 · product code KPS · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The Siemens Biograph Horizon PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph Horizon systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software. Biograph Horizon software is a command-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements. The software for the Biograph Horizon systems which is the subject of this application is substantially equivalent to the commercially available Biograph Horizon software. Modifications include, corrections to software anomalies and addition of new software features, including: OncoFreeze, OncoFreeze AI (Data Driven Gating), CardioFreeze, FlowMotion Multi-Parametric PET AI”
source quote (p.5)
“Modifications include, corrections to software anomalies and addition of new software features, including: OncoFreeze, OncoFreeze AI (Data Driven Gating), CardioFreeze, FlowMotion Multi-Parametric PET AI, PET FAST Planning (FlowMotion AI)”
source quote (p.9)
“Cybersecurity information in accordance with FDA Guidance documents issued October 2, 2014 has been provided. The Biograph Horizon software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use. Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed or transferred between the Biograph Horizon and external devices.”
Validation studies (5)
Bench
sample size not stated
endpoints: Resolution - Full Size; Resolution - 256 x 256; Count Rate / Scatter / Sensitivity; Image Quality (4 to 1) - (% Contrast / Background Variability); Co-registration Accuracy
standards: NEMA NU2-2018
Bench
sample size not stated
endpoints: change in SUVmax; SUVmean; Volume measurement
Bench
sample size not stated
endpoints: improved noise characteristics; better delineation of organs and tumors
Bench
sample size not stated
endpoints: accuracy with which FlowMotion AI correctly defined the bed ranges; Successful identification of all ranges
Bench
n=1 other
endpoints: evaluate ROIs using Single Bed Scatter compared to whole body scatter correction; Representative region of interest close to phantom exhibiting high signal; Representative region of interest close to phantom exhibiting low signal; Representative region of interest inside phantom
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code KPS (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel, initiated 2025-12-24): "There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most eas" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98269
- recall_reason_pattern
Software/algorithm-related recall in product code KPS (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel, initiated 2025-06-20): "Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector mo" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97193
- recall_reason_pattern
Software/algorithm-related recall in product code KPS (Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden, initiated 2024-10-31): "Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95673
- recall_reason_pattern
Software/algorithm-related recall in product code KPS (Canon Medical System, USA, INC., initiated 2024-09-17): "When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95471
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).