Biograph Horizon

K193178

Siemens Medical Solution USA, Inc. · cleared 2020-02-12 · product code KPS · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.3)
“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. Modifications include, corrections to software anomalies and addition of new software features, including: OncoFreeze AI (Data Driven Gating) FlowMotion Multi-Parametric PET AI”
AlgorithmOncoFreeze AI (Data Driven Gating), FlowMotion Multi-Parametric PET AI, FlowMotion AI (PET FAST Planning)
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”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
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: change in SUVmax; change in SUVmean; change in Volume

Bench

sample size not stated

endpoints: improved noise characteristics; better delineation of organs and tumors

Bench

sample size not stated

endpoints: successful identification of all ranges

Bench

sample size not stated

endpoints: 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

Bench

sample size not stated

endpoints: Transverse Resolution FWHM @ 1 cm; Transverse Resolution FWHM @ 10 cm; Transverse Resolution FWHM @ 20 cm; Axial Resolution FWHM @ 1 cm; Axial Resolution FWHM @ 10 cm; Axial Resolution FWHM @ 20 cm; Sensitivity @435 keV LLD; Count Rate peak NECR; Count Rate peak trues; Scatter Fraction at peak NECR; Mean bias (%) at peak NEC; 10mm sphere % Contrast; 10mm sphere Background Variability; 13mm sphere % Contrast; 13mm sphere Background Variability; 17mm sphere % Contrast; 17mm sphere Background Variability; 22mm sphere % Contrast; 22mm sphere Background Variability; 28mm sphere % Contrast; 28mm sphere Background Variability; 37mm sphere % Contrast; 37mm sphere Background Variability; Max Error Co-Registration Accuracy

standards: NEMA NU2-2018

Reported performance (2 observations)

sensitivity5.8
source quote (p.7)
“Sensitivity @435 keV LLD Pass ≥ 5.8 cps/kBq ≥ 10.9 cps/kBq (TrueV)”
accuracyas written: “Max Error Co-Registration Accuracy”5
source quote (p.7)
“Max Error Pass ≤ 5 mm”

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

34
recalls in product code, 24mo
8
MAUDE reports in code, 12mo
-72%
vs code's own 3-yr baseline
4
drift signals on this device
  • 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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc.) — same firm and product code, not necessarily this device · initiated 2023-07-12

    During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.

    recall event 92704 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc.) — same firm and product code, not necessarily this device · initiated 2023-01-16

    This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

    recall event 91518 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc.) — same firm and product code, not necessarily this device · initiated 2023-01-16

    This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

    recall event 91518 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc.) — same firm and product code, not necessarily this device · initiated 2023-01-16

    This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

    recall event 91518 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K193178