FDA-cleared profile
ABBOTT MEDICAL
Authorized purpose: Abbott OPTIS Mobile or Integrated Next with Ultreon 3.0 processes compatible coronary intravascular OCT data to support visualization, measurement, and interventional assessment of coronary vessels.
Product overview
Authorized purpose: Abbott OPTIS Mobile or Integrated Next with Ultreon 3.0 processes compatible coronary intravascular OCT data to support visualization, measurement, and interventional assessment of coronary vessels.
Overview status: Source-reviewed overview
Clinical role: Abbott OPTIS Mobile or Integrated Next with Ultreon 3.0 processes compatible coronary intravascular OCT data to support visualization, measurement, and interventional assessment of coronary vessels.
Evidence from the reviewed source record: The exact FDA decision material describes the labeled intended use and submission-level verification for this release. It does not establish a product-wide clinical sensitivity or specificity claim or independent clinical outcome evidence.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Deployment details for the exact cleared configuration are not established in the public FDA decision material.
Security controls, hosting boundaries, audit behavior, identity management, and incident commitments for the exact configuration are not established in the public FDA decision material.
Post-deployment monitoring, drift thresholds, alerting, and revalidation commitments for the exact configuration require vendor and site confirmation.
Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K253459 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
Uses a compatible coronary intravascular OCT catheter and imaging system in the interventional laboratory; local archive and downstream data interfaces require acceptance.
exact submission · checked 2026-09-04Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
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 FDA material excludes specified left-main and prior-bypass contexts; the device is an adjunct to professional interventional judgment.
exact submission · checked 2026-09-04Define stop-use, escalation, rollback, and revalidation triggers before production use.
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 2026-09-04No exact-product price was found in the evidence set; productivity or value claims require local evidence.
Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes; exact monitoring thresholds and vendor commitments are unknown.
exact submission · checked 2026-09-04Establish ownership for data quality, overrides, drift, incidents, recalls, and change control.
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.
No exact-product, version-specific sensitivity endpoint was established for this submission in the evidence set.
No exact-product, version-specific specificity endpoint was established for this submission in the evidence set.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K253459
Evidence submitted for the exact FDA decision is not independent clinical validation. Local technical, clinical, privacy, security, and workflow acceptance remains necessary.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared configuration was found in the evidence set. Obtain a written quote covering license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, downtime, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesReviewed CMS material is not a product-specific price or coverage determination; do not infer reimbursement from FDA clearance.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
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, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Regulatory record
510(k)
Research record
human reviewed
Editorial review
Source-reviewed editorial overlay
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