Radiology AI Directory

FDA-cleared profile

Trinias

Shimadzu Corporation

Authorized purpose: Trinias is an interventional fluoroscopic X-ray system for diagnostic and interventional angiography, including cardiac, neurovascular, abdominal, peripheral, rotational, multipurpose, and whole-body radiographic or fluoroscopic procedures.

Cardiac imaging
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: Trinias is an interventional fluoroscopic X-ray system for diagnostic and interventional angiography, including cardiac, neurovascular, abdominal, peripheral, rotational, multipurpose, and whole-body radiographic or fluoroscopic procedures.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Trinias is an interventional fluoroscopic X-ray system for diagnostic and interventional angiography, including cardiac, neurovascular, abdominal, peripheral, rotational, multipurpose, and whole-body radiographic or fluoroscopic procedures.

Evidence takeaway

Evidence from the reviewed source record: The exact FDA decision material describes the labeled angiographic and radiographic workflows and system verification. The short public decision document does not establish a product-wide clinical sensitivity or specificity claim.

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
Trinias is an interventional fluoroscopic X-ray system for diagnostic and interventional angiography, including cardiac, neurovascular, abdominal, peripheral, rotational, multipurpose, and whole-body radiographic or fluoroscopic procedures.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified radiologists, interventional physicians, surgeons, technologists, and other trained fluoroscopy professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Hospital radiography, fluoroscopy, interventional, vascular, cardiac, or procedural departments.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Fluoroscopic or radiographic acquisition, visualization, guidance, and release-specific image processing.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
X-ray projection data, fluoroscopic sequences, patient positioning, contrast or procedure inputs, and user selections.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Radiographic or fluoroscopic images, overlays, measurements, and procedure views for professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Operator selection, patient positioning, contrast, radiation dose, anatomy, calibration, and procedure-specific conditions affect applicability; treating physicians remain responsible for decisions.
  • 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
K252099
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Fluoroscopy/Angiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Heart, neurovascular, abdominal, peripheral vessels, and whole body
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-03-24
  • 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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

The public exact-submission material does not establish a complete integration contract. Confirm DICOM, worklist, identity, interfaces, exports, routing, audit behavior, and downtime locally.

Deployment and data flow
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

The public exact-submission material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-04

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 radiologists, interventional physicians, surgeons, technologists, and other trained fluoroscopy professionals 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 2026-09-04
Monitoring and change control
Monitor by exact hardware, software, model, and algorithm 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: Operator selection, patient positioning, contrast, radiation dose, anatomy, calibration, and procedure-specific conditions affect applicability; treating physicians remain responsible for decisions.
  • Public source
  • Product family
  • Checked 2026-09-04

Current vendor material is product-family context for K252099; confirm exact cleared version, enabled options, deployment, and local compatibility.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K252099 before acceptance.

exact submission · checked 2026-09-04

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

Source

Interoperability acceptance

Exact public integration details remain incomplete; establish and test the supported input, output, identity, routing, archive, and downtime contract locally.

product family · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Current vendor material is product-family context; confirm exact release, enabled options, deployment, and local compatibility.

SourceSource

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. Operator selection, patient positioning, contrast, radiation dose, anatomy, calibration, and procedure-specific conditions affect applicability; treating physicians remain responsible for decisions.

exact submission · checked 2026-09-04

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 2026-09-04

No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.

Source

Lifecycle monitoring

Monitor by exact hardware, software, model, and algorithm 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: Operator selection, patient positioning, contrast, radiation dose, anatomy, calibration, and procedure-specific conditions affect applicability; treating physicians remain responsible for decisions.

product family · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Current vendor material is product-family context; confirm exact release, enabled options, deployment, and local compatibility.

SourceSource

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 decision material describes the labeled angiographic and radiographic workflows and system verification. The short public decision document does not establish a product-wide clinical sensitivity or specificity claim.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Sensitivity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if one is later verified.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Specificity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if one is later verified.

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

K252099 FDA evidence package for Trinias

  • DesignFDA substantial-equivalence decision with system, software, image-quality, safety, EMC, and usability verification
  • PopulationAdult diagnostic and interventional angiography and radiographic or fluoroscopic procedures across the exact labeled anatomy
  • Scopeexact submission
  • Tested versionK252099 exact FDA configuration
  • IndependenceSponsor or vendor study

K252099

Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, 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 2026-09-04

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, 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 2026-09-04

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 K252099 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

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.

Human reviewedStatus
2026-09-20Last searched
27Fields reviewed
12Source 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. 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 material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, 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 510(k) decision material K252099: Trinias

    U.S. Food and Drug Administration - Published 2026-03-24 - Accessed 2026-09-04

    Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, 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. 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

  7. Shimadzu Trinias angiography family

    Shimadzu Corporation - Accessed 2026-09-04

    Scope: productFamilyContext, workflowRole, implementationCapabilities

Research history

  1. K252099 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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