Radiology AI Directory

FDA-cleared profile

Auto Positioning

GE Hangwei Medical Systems, Co., Ltd.

Authorized purpose: Auto Positioning uses 3D patient-position information and the selected CT protocol to suggest scout range, orientation, table height, and collision checks before a technologist-approved first scout.

CT/CTA workflow
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: Auto Positioning uses 3D patient-position information and the selected CT protocol to suggest scout range, orientation, table height, and collision checks before a technologist-approved first scout.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Auto Positioning uses 3D patient-position information and the selected CT protocol to suggest scout range, orientation, table height, and collision checks before a technologist-approved first scout.

Evidence takeaway

Evidence from the reviewed source record: K192956 reports manufacturer camera, positioning, software, workflow, and safety validation for supported patient orientations and protocols.

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
Auto Positioning uses 3D patient-position information and the selected CT protocol to suggest scout range, orientation, table height, and collision checks before a technologist-approved first scout.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
CT technologist.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The indications statement names the CT technologist and does not establish interpreting or treating physicians as an intended-user class.

Care setting and population
Hospital and outpatient CT, interventional, oncology, or radiotherapy departments within the cleared scope.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
CT acquisition, reconstruction, visualization, and release-specific examination planning.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
3D spatial information of the individual patient on the table and information from the selected protocol.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The packet describes camera-derived 3D spatial information combined with the selected protocol, not X-ray projection data.

Output and human action
Auto Positioning acquires 3D spatial information of the individual patient on the table and combines it with information from the selected protocol to automatically calculate and visually display the scout's start and end locations. Concurrently it checks for proper patient orientation, determines the table height for optimum patient centering, and checks for potential contact between the patient and the gantry. Upon acceptance by the technologist the patient is automatically moved to the correct scout start location.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The packet's output is the scout setup and safety-check workflow, not cross-sectional images, measurements, or planning datasets.

Limitations
Incorporation of this optional feature does not preclude the technologist from performing the existing manual workflow on the CT system, if desired.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

This is the packet's direct manual-workflow boundary; the broader replacement and safety wording in the dossier is not stated.

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
K192956
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The classification name is a computed tomography x-ray system; the packet does not state CTA as the modality label. Controlled directory display reconciled from exact FDA wording: Computed tomography x-ray system. -> CT/CTA.

Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2020-01-16
  • 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
Scanner-console and DICOM workflow to PACS, advanced visualization, and treatment-planning systems; validate worklist, protocol, dose record, geometry, series labels, and routing.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Installed CT scanner hardware, console software, reconstruction options, and supported accessories.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only qualified ct technologists and trained interpreting or treating physicians. should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track these product-specific limits: The technologist must review and accept suggested motion and scan setup; the feature does not replace positioning, collision, protocol, or patient-safety checks.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K192956 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

Scanner-console and DICOM workflow to PACS, advanced visualization, and treatment-planning systems; validate worklist, protocol, dose record, geometry, series labels, and routing.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. The technologist must review and accept suggested motion and scan setup; the feature does not replace positioning, collision, protocol, or patient-safety checks.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track these product-specific limits: The technologist must review and accept suggested motion and scan setup; the feature does not replace positioning, collision, protocol, or patient-safety checks.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

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
K192956 reports manufacturer camera, positioning, software, workflow, and safety validation for supported patient orientations and protocols.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Specificity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

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

K192956 FDA performance package for Auto Positioning

  • DesignManufacturer positioning-accuracy, software, workflow, and safety validation
  • PopulationSupported CT patient-positioning and scout-planning workflows
  • Scopeexact submission
  • Tested versionAuto Positioning release cleared in K192956
  • IndependenceSponsor or vendor study

K192956

Manufacturer evidence submitted for clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

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 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

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
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K192956 by exact submission identifier. This does not exclude product-family or later safety information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

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.

Exact FDA record reviewedStatus
2026-09-20Last searched
27Fields reviewed
11Source classes checked
14Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 14 PubMed and 0 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 14 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 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, fda decision material, reimbursement policy, fda device recall, fda decision summary packet, 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 K192956: Auto Positioning

    U.S. Food and Drug Administration - Published 2020-01-16 - Accessed 2026-09-19

    Scope: purpose, anatomy, evidenceSummary, modality, intendedUsers, input, output, limitations, clinicalUse

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

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

    Scope: coverage, codingContext

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K192956 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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