FDA-approved profile
Seno Medical Instruments, Inc.
Imagio combines ultrasound and optoacoustic imaging to evaluate palpable or non-palpable breast abnormalities in adults referred for diagnostic workup. Ultrasound can assign BI-RADS, and optoacoustic features can assist assessment of BI-RADS 3-5 masses based on vascularity and blood oxygen saturation.
Clinical fit
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.
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.
Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to P200003 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Validate the acquisition console, data storage, image review, patient matching, report workflow, and any export or archive interface.
exact submission · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. The capability is derived from the exact FDA workflow and still requires local acceptance testing.
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 system is adjunctive to diagnostic workup and is not a replacement for mammographic screening or definitive pathology. Use optoacoustic assessment only for labeled BI-RADS 3-5 masses and review the underlying ultrasound and clinical context.
exact submission · checked 2026-09-03Define 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 2026-09-03No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.
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: The system is adjunctive to diagnostic workup and is not a replacement for mammographic screening or definitive pathology. Use optoacoustic assessment only for labeled BI-RADS 3-5 masses and review the underlying ultrasound and clinical context.
exact submission · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. The capability is derived from the exact FDA workflow and still requires local acceptance testing.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
Specificity is not the primary endpoint for this system, 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.
FDA PMA review of analytical, clinical, usability, and optoacoustic breast-imaging evidence · Adults with palpable or non-palpable breast abnormalities referred for diagnostic workup after clinical presentation or prior imaging
exact submission · Tested version: Imagio Breast Imaging System · Sponsor or vendor studyP200003
Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.
ClinicalTrials.gov candidate identified by exact-name search; full product and version applicability review pending · Breast or related Optoacoustic Imaging workflow; exact product and version linkage not established
product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not establishedNCT02364388
Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.
ClinicalTrials.gov candidate identified by exact-name search; full product and version applicability review pending · Breast or related Optoacoustic Imaging workflow; exact product and version linkage not established
product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not establishedNCT01943916
Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.
Economics and lifecycle
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. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
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.
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials were reviewed for identity, indication, users, workflow, limitations, and submitted performance. Current vendor material is labeled product-family context where it does not establish the exact release. PubMed and ClinicalTrials.gov results are retained as candidate evidence with version applicability pending; CMS reimbursement context and exact-identifier openFDA postmarket results were also checked. Pricing, final security architecture, contracted services, enabled options, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 0 PubMed and 3 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, fda decision summary, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-03.
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