Radiology AI Directory

FDA-approved profile

SECOND LOOK ™

ICAD, INC.

Authorized purpose: The Second Look computer-aided detection system for mammography is intended to identify and mark regions of interest on standard mammographic views after the initial reading has been completed, bringing them to the radiologist's attention and helping minimize observational oversights by identifying areas that may warrant a second review.

Breast imagingDetection and CADe
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: The Second Look computer-aided detection system for mammography is intended to identify and mark regions of interest on standard mammographic views after the initial reading has been completed, bringing them to the radiologist's attention and helping minimize observational oversights by identifying areas that may warrant a second review.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: The Second Look computer-aided detection system for mammography is intended to identify and mark regions of interest on standard mammographic views after the initial reading has been completed, bringing them to the radiologist's attention and helping minimize observational oversights by identifying areas that may warrant a second review.

Evidence takeaway

Evidence from the reviewed source record: P010034 FDA decision material identifies the exact cleared or authorized product, intended use, labeled anatomy and modality, and submission-specific verification. It does not by itself establish product-wide sensitivity, specificity, outcomes, reimbursement, or independent clinical validation for this exact configuration.

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
The Second Look computer-aided detection system for mammography is intended to identify and mark regions of interest on standard mammographic views after the initial reading has been completed, bringing them to the radiologist's attention and helping minimize observational oversights by identifying areas that may warrant a second review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Radiologists, dentists, orthopedic clinicians, and other trained radiographic professionals within the labeled use.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Radiographic, orthopedic, dental, or clinical image-review settings within the labeled scope.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Radiographic image acquisition support, image processing, measurement, planning, or concurrent review under professional control.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported X-ray, radiographic, EOS, dental, or other labeled image inputs and associated study data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Processed radiographs, measurements, landmarks, annotations, planning views, and review information for professional use.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The exact PMA approval-order statement describes a post-initial-reading second-look aid for standard mammographic views; it does not replace the radiologist's examination or judgment.
  • 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
P010034
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Mammography/DBT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Breast / standard mammographic views
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
PMA
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2002-01-31
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-approved
  • 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 exact public FDA decision material does not establish a complete integration contract. Confirm supported inputs, outputs, identity, routing, archive behavior, 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 exact public FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • 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 radiologists, dentists, orthopedic clinicians, and other trained radiographic professionals within the labeled use 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 P010034 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 exact PMA approval-order statement describes a post-initial-reading second-look aid for standard mammographic views; it does not replace the radiologist's examination or judgment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to P010034 before acceptance.

exact submission · checked 2026-09-04

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

Source

Deployment boundary

The exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.

exact submission · checked 2026-09-04

FDA-described topology does not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The exact public integration contract remains incomplete; establish and test supported input, output, identity, routing, archive, and downtime behavior locally.

exact submission · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source

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 exact PMA approval-order statement describes a post-initial-reading second-look aid for standard mammographic views; it does not replace the radiologist's examination or judgment.

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.

exact submission · checked 2026-09-04

No exact-product price or reimbursement determination was promoted.

Source

Lifecycle monitoring

Monitor P010034 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 exact PMA approval-order statement describes a post-initial-reading second-look aid for standard mammographic views; it does not replace the radiologist's examination or judgment.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

Source

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
P010034 FDA decision material identifies the exact cleared or authorized product, intended use, labeled anatomy and modality, and submission-specific verification. It does not by itself establish product-wide sensitivity, specificity, outcomes, reimbursement, or independent clinical validation for this exact configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.

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

Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.

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

P010034 FDA decision evidence package for SECOND LOOK ™

  • DesignFDA decision evidence and product verification described in the exact submission or PMA decision record.
  • PopulationBreast / standard mammographic views
  • Scopeexact submission
  • Tested versionSECOND LOOK ™ configuration described in P010034
  • IndependenceSponsor or vendor study

P010034

FDA decision material is manufacturer-submitted regulatory evidence. It is not independent clinical validation unless the exact source expressly establishes that distinction; 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 or authorized configuration was found. Obtain a written quote separating license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-product reimbursement determination was promoted in this timeboxed review. Verify payer, site-of-service, coding, coverage, and local payment assumptions independently.

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 P010034 by exact native submission identifier. This does not exclude product-family, later-version, 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.

Exact FDA record reviewedStatus
2026-09-20Last searched
27Fields reviewed
8Source classes checked
20Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 20 PubMed and 0 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 20 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, 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 PMA decision material P010034: SECOND LOOK ™

    U.S. Food and Drug Administration - Published 2002-01-31 - 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. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. P010034 FDA decision

    Regulatory record

    PMA

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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