FDA-authorized profile
Ultrasound AI
Delivery Date AI analyzes obstetric ultrasound images to provide a predicted delivery date for singleton pregnancies in women age 18 or older at 14 0/7 through 36 6/7 weeks when the last-menstrual-period date or first-trimester ultrasound is unreliable or unavailable; the output is an aid to clinical judgment.
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.
The public exact-submission material does not establish a complete integration contract. Confirm DICOM, worklist, identity, interfaces, exports, routing, audit behavior, and downtime locally.
The public exact-submission material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.
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.
Current vendor material is product-family context for DEN250007; confirm exact cleared version, enabled options, deployment, and local compatibility.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to DEN250007 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
Exact public integration details remain incomplete; establish and test the supported input, output, identity, routing, archive, and downtime contract locally.
product family · checked 2026-09-04Test 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.
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 output is an aid and not a replacement for standard gestational-age methods or clinical judgment; the labeled singleton, age, gestational-age, dating-history, image-quality, and clinical-use limits apply.
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 reviewed public material; productivity or value claims require local evidence.
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 output is an aid and not a replacement for standard gestational-age methods or clinical judgment; the labeled singleton, age, gestational-age, dating-history, image-quality, and clinical-use limits apply.
product family · checked 2026-09-04Revalidate 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.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
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.
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.
FDA De Novo decision with machine-learning software, risk-control, analytical, clinical-image, and usability evidence described in the exact submission · Singleton pregnancies in women age 18 or older at 14 0/7 through 36 6/7 weeks without a reliable estimated due date from the labeled standard methods
exact submission · Tested version: Delivery Date AI configuration described in DEN250007 · Sponsor or vendor studyDEN250007
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.
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.
This submission was added after the prior exact-submission extraction and remains queued for source review. Exact-name and exact-submission searches in the checked 2026-09-01 indexes returned no PubMed records and no ClinicalTrials.gov records for DEN250007; review status is candidate_review_pending. Any candidate literature or registry record remains quarantined as product-family evidence unless exact submission and version linkage is established. Current vendor material is product-family context. Pricing, complete security architecture, contracted deployment, exact reimbursement, and local interoperability remain unverified. Automated exact-name discovery found 0 PubMed and 0 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 material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
Alternatives
Sonic Incytes
Velacur Sonic measures liver tissue stiffness, ultrasound attenuation, and volume density fat fraction with shear-wave and ultrasound measurements to aid clinical management of...
Siemens Medical Solutions USA, Inc.
The ACUSON Sequoia and Sequoia Select systems provide ultrasound images or signals for the labeled fetal, abdominal, pediatric, neonatal cephalic, small-parts, OB/GYN, cardiac,...
Sonic Incytes
Velacur Sonic measures liver tissue stiffness and ultrasound attenuation to aid clinical management of liver disease within the labeled workflow.
Philips Ultrasound, LLC
Alturion Series diagnostic ultrasound systems acquire and display ultrasound images and fluid-flow information for the labeled fetal, abdominal, cardiac, cephalic, obstetric,...