FDA-approved profile
ICAD, INC.
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.
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 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.
The exact public FDA decision 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.
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.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to P010034 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared or authorized release includes them.
The exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.
exact submission · checked 2026-09-04FDA-described topology does not establish current hosting contracts, security controls, uptime, or local qualification.
The exact public integration contract remains incomplete; establish and test supported input, output, identity, routing, archive, and downtime behavior locally.
exact submission · checked 2026-09-04Test 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 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 2026-09-04Define 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.
exact submission · checked 2026-09-04No exact-product price or reimbursement determination was promoted.
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 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.
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.
FDA decision evidence and product verification described in the exact submission or PMA decision record. · Breast / standard mammographic views
exact submission · Tested version: SECOND LOOK ™ configuration described in P010034 · Sponsor or vendor studyP010034
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.
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 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.
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
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. Scope was limited to exact FDA decision material and exact-submission recall disposition already present in the checked snapshot. Optional literature, vendor, pricing, and deployment research was not promoted. Automated exact-name discovery found 20 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, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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