Radiology AI Directory

FDA-authorized profile

Delivery Date AI

Ultrasound AI

Authorized purpose: 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.

Oncology quantificationUltrasound workflow
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: 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.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: 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.

Evidence takeaway

Evidence from the reviewed source record: The exact FDA De Novo decision material describes the software-only radiological system, labeled pregnancy and dating-history criteria, the risk of inappropriate management from inaccurate prediction, and special controls. No generic obstetric outcome or universal accuracy claim is inferred.

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
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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified obstetricians, maternal-fetal-medicine specialists, sonographers, and other trained healthcare professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Clinical obstetric ultrasound settings using labeled pregnancy dating workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Obstetric-image analysis that provides a predicted delivery date as an aid to clinical judgment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported obstetric ultrasound images from singleton pregnancies within the labeled gestational-age and dating-history conditions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
A predicted delivery date and associated workflow display for clinician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
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.
  • 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
DEN250007
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Pregnancy and obstetric anatomy
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
De Novo
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-02-11
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-authorized
  • 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 obstetricians, maternal-fetal-medicine specialists, sonographers, and other trained healthcare 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: 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.
  • Public source
  • Product family
  • Checked 2026-09-04

Current vendor material is product-family context for DEN250007; 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 DEN250007 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. 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 2026-09-04

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: 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 2026-09-04

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 De Novo decision material describes the software-only radiological system, labeled pregnancy and dating-history criteria, the risk of inappropriate management from inaccurate prediction, and special controls. No generic obstetric outcome or universal accuracy claim is inferred.
  • 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.

DEN250007 FDA evidence package for Delivery Date AI

  • DesignFDA De Novo decision with machine-learning software, risk-control, analytical, clinical-image, and usability evidence described in the exact submission
  • PopulationSingleton 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
  • Scopeexact submission
  • Tested versionDelivery Date AI configuration described in DEN250007
  • IndependenceSponsor or vendor study

DEN250007

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 DEN250007 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 De Novo decision material DEN250007: Delivery Date AI

    U.S. Food and Drug Administration - Published 2026-02-11 - 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. Ultrasound AI product family

    Ultrasound AI - Accessed 2026-09-04

    Scope: productFamilyContext, workflowRole, implementationCapabilities

Research history

  1. DEN250007 FDA decision

    Regulatory record

    De Novo

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

Alternatives

Related tools to compare

FDA-cleared K232145

ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System

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,...

Modality
Ultrasound
Anatomy
Fetal, abdominal, pediatric, neonatal cephalic, small parts, OB/GYN, cardiac, pelvic, vascular, adult cephalic, musculoskeletal, peripheral vascular, intracardiac, and intraluminal cardiac or great-vessel anatomy
Decision
2023-10-30
Cardiac imagingOncology quantificationQuantification and segmentation