Ultrasound hardware coupling
The exact labeling describes a PIUR sensor clipped to a transducer with a bracket and position data transferred by Bluetooth.
exact submission · checked 2026-09-06FDA-cleared profile
PIUR tUS inside
PIUR Imaging GmbH
3D ultrasound reconstruction with physician-reviewed thyroid and nodule quantification and sonographic feature visualization.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
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
- 3D ultrasound reconstruction with physician-reviewed thyroid and nodule quantification and sonographic feature visualization.
- Intended users
- Trained healthcare professionals performing or interpreting thyroid ultrasound examinations.
- Care setting and population
- Ultrasound examination settings using a compatible GE Healthcare ultrasound system.
- Workflow role
- Adjunct 3D reconstruction and quantitative visualization tool; the user reviews the reconstructed volume, annotations and report.
- Required input
- 2D ultrasound images plus PIUR sensor position data captured while the transducer is moved perpendicular to the thyroid structure.
- Output and human action
- An unlimited-length 3D volume intended to cover a thyroid lobe, user-selected or algorithm-suggested lobe and nodule volumes, sonographic feature views, annotated screenshots, reports and DICOM Secondary Capture objects.
- Limitations
- The reviewed labeling requires compatible GE ultrasound equipment and trained use; manual ACR TI-RADS assessment and clinician review remain part of the workflow.
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.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The exact submission describes DICOM Secondary Capture storage objects and report outputs; the current PIUR resource set publishes DICOM and user-manual resources, but current site-specific integration was not established.
- Deployment and data flow
- FDA materials describe a Windows-based application running directly on compatible GE LOGIQ E10, E10s and Fortis systems.
- Security and privacy
- Vendor documentation pending
No current exact-release security attestation was established.
- Training and support
- PIUR publishes user manuals and training resources for the inside family; the exact K250484 onboarding or competency package was not established.
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
GE system installation
The current family manual describes installation on compatible GE ultrasound systems and use of official brackets; exact K250484 installation steps are not established from that family manual.
product family · checked 2026-09-07DICOM and report resources
PIUR publishes DICOM files, user manuals and training materials for its product family.
product family · checked 2026-09-07Evidence
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 FDA summary establishes the reconstruction workflow and DICOM/report outputs; it does not provide a numeric clinical performance endpoint in the reviewed summary.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
PIUR tUS inside reconstruction and DICOM performance validation
- DesignBench and workflow validation
- PopulationThyroid ultrasound acquisitions using the reviewed compatible equipment and sensor workflow
- Scopeexact submission
- Tested versionPIUR tUS inside release reviewed in K250484
- IndependenceSponsor or vendor study
K250484 FDA 510(k) summary
The reviewed FDA summary describes DICOM compliance and performance validation without a public numeric endpoint.
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
No numeric price was published in the reviewed sources.
- Reimbursement and coding
- Research pending
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
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
- Not established in reviewed sources
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: No current exact-release security attestation was established.
- Verify pricing and total cost: No numeric price was published in the reviewed sources.
- Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
- Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
21Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The stored candidate metadata contained empty PubMed and clinical-trial ID arrays; metadata was screened, not full-text or registry-reviewed. The stored recall candidate record was empty and no event 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. 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, acr ai central product, vendor product page, vendor manual, peer reviewed publication, clinical trial registry, recall database, 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
-
K250484 FDA decision source
Scope: regulatoryIdentity, purpose, modality, anatomy
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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PIUR tUS inside model card (K250484)
Scope: intendedUsers, careSetting, output, evidenceSummary, anatomy, evidenceStudies
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
FDA 510(k) decision record and summary reviewed for PIUR tUS inside, K250484
Scope: identity, intended_use, performance, limitations, implementation
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PIUR tUS inside User Manual, English revision 15.0
Scope: product_family, clinical_workflow, outputs, limitations, installation
-
PIUR Imaging resources
Scope: product_family, manuals, training_resources, DICOM_resources
Research history
-
K250484 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
human reviewed
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