Radiology AI Directory

FDA-cleared profile

Biograph Horizon

Siemens Medical Solution USA, Inc.

Authorized purpose: Biograph Horizon is a PET/CT system for the labeled molecular-imaging acquisition, reconstruction, fusion, visualization, and professional-interpretation workflow.

Nuclear medicine
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: Biograph Horizon is a PET/CT system for the labeled molecular-imaging acquisition, reconstruction, fusion, visualization, and professional-interpretation workflow.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Biograph Horizon is a PET/CT system for the labeled molecular-imaging acquisition, reconstruction, fusion, visualization, and professional-interpretation workflow.

Evidence takeaway

Evidence from the reviewed source record: The exact FDA submission K193178 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Biograph Horizon is a PET/CT system for the labeled molecular-imaging acquisition, reconstruction, fusion, visualization, and professional-interpretation workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified nuclear medicine physicians, radiologists, technologists, and other trained PET/CT professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Hospital or outpatient molecular-imaging departments using the cleared PET/CT configuration and labeled workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
PET/CT acquisition, reconstruction, attenuation correction, fusion, visualization, and professional review support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Positron-emission data, CT transmission data, patient information, protocol information, and supported radiopharmaceutical studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
PET, CT, fused PET/CT, quantitative, and planning image series for professional interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Radiopharmaceutical, scan range, patient-size, acquisition, reconstruction, attenuation-correction, dose, and quantitative limits are configuration-specific. Biograph Horizon is a PET/CT system for the labeled molecular-imaging acquisition, reconstruction, fusion, visualization, and professional-interpretation workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K193178
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
PET/SPECT/Nuclear Medicine
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2020-02-12
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Workflow role

PET/CT acquisition, reconstruction, attenuation correction, fusion, visualization, and professional review support.

exact submission · checked 2026-09-04

This is a submission-anchored intended-use summary, not a local acceptance result.

Source

Input

Positron-emission data, CT transmission data, patient information, protocol information, and supported radiopharmaceutical studies.

exact submission · checked 2026-09-04

Exact supported inputs and protocol limits must be confirmed from the complete labeling.

Source

Output

PET, CT, fused PET/CT, quantitative, and planning image series for professional interpretation.

exact submission · checked 2026-09-04

Output review, editing, and downstream use remain release- and site-specific.

Source

Vendor family context

Current vendor material is product-family context for K193178 only; exact release, enabled options, deployment, and local interoperability require confirmation.

product family · checked 2026-09-04

Vendor material is not exact-release evidence unless that linkage is separately proven.

Source

Site validation status

Exact local interfaces, deployment topology, security controls, downtime behavior, and support obligations remain unestablished.

exact submission · checked 2026-09-04

Obtain organization-specific implementation evidence before procurement or clinical use.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
The exact FDA submission K193178 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact submission and version-linked sensitivity endpoint is published in this dossier; do not substitute a product-family or candidate-study value.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact submission and version-linked specificity endpoint is published in this dossier; do not substitute a product-family or candidate-study value.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

FDA submission-specific verification and validation evidence for K193178

  • DesignRegulatory verification, validation, and labeling evidence reviewed for exact FDA submission K193178.
  • PopulationThe labeled population and test materials for exact submission K193178; a general clinical study population is not established here.
  • Scopeexact submission
  • Tested versionBiograph Horizon (K193178)
  • IndependenceSponsor or vendor study

K193178

FDA regulatory evidence is submission-specific but is not independent clinical performance evidence.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review.

Reimbursement and coding
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

CMS index context was checked, but no product-specific coverage or reimbursement determination is inferred.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
FDA recall Z-1134-2023 is associated with native exact submission identifier K193178. Status: Open, Classified. Product: SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission. Reason: This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.

recall: Z-1134-2023

Open, Classified

2023-02-13

Native exact-submission identifier match from the openFDA candidate snapshot accessed 2026-09-04 with source snapshot date 2026-09-02. Source URL: https://api.fda.gov/device/recall.json?search=product_res_number.exact%3A%22Z-1134-2023%22&limit=1. This does not establish exact installed serial, lot, unit, or software-version applicability.

Source

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
29Fields reviewed
13Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. 1 FDA recall candidate was manually reviewed: 1 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 1 postmarket candidate record; 1 has been reviewed (1 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, vendor product page, implementation documentation, reimbursement policy, peer reviewed literature, clinical trial registry, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA decision summary for K193178 - Biograph Horizon

    U.S. Food and Drug Administration - Published 2020-02-12 - Accessed 2026-09-04

    Scope: regulatoryIdentity, productIdentity, indication, modality, anatomy, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. FDA recall Z-1134-2023: SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission

    U.S. Food and Drug Administration - Published 2023-02-13 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  8. Siemens Healthineers Biograph PET/CT family context

    Siemens Healthineers - Accessed 2026-09-04

    Scope: productFamilyContext, workflowRole, implementationCapabilities

Research history

  1. K193178 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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