Radiology AI Directory

FDA-cleared profile

MammoSightAI

Neurocareai, Inc. (Dba Savelife.Ai)

Authorized purpose: Tags screening cases as suspicious or blank to aid worklist prioritization; radiologists must review every examination and it does not mark original images.

Breast imagingAcute triage and notification
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: Tags screening cases as suspicious or blank to aid worklist prioritization; radiologists must review every examination and it does not mark original images.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Tags screening cases as suspicious or blank to aid worklist prioritization; radiologists must review every examination and it does not mark original images.

Evidence takeaway

Evidence from the reviewed source record: Retrospective blinded standalone evidence is exact-submission regulatory evidence; vendor marketing numbers were not substituted for FDA endpoints.

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
Tags screening cases as suspicious or blank to aid worklist prioritization; radiologists must review every examination and it does not mark original images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Radiologists interpreting screening breast examinations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Care setting and population
Adult
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Triage or notification support
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Required input
Compatible FFDM and DBT DICOM screening examinations; validation population was women aged 35 years and older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Output and human action
Suspicious or blank worklist tag, a nondiagnostic Secondary Capture preview and Structured Report.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Limitations
Passive triage only: it cannot remove cases, is not standalone, and output does not annotate original diagnostic images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

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
K252954
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Mammography/DBT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Anatomy
Breast
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-05-04
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • 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
Current SaveLife.AI family material describes DICOM integration with PACS/RIS and RadioViewAI/ConnectAI workflows.
  • Vendor supplied
  • Product family
  • Checked 2026-09-05

Not an exact submission interface guarantee.

Deployment and data flow
The summary describes both on-premises and cloud deployment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact product version
  • Checked 2026-09-05
Training and support
Not established in reviewed sources
  • Reviewed sources checked
  • Exact product version
  • Checked 2026-09-05
Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Family DICOM integration

Current AI Suite materials describe PACS/RIS DICOM integration.

product family · checked 2026-09-05
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
Retrospective blinded standalone evidence is exact-submission regulatory evidence; vendor marketing numbers were not substituted for FDA endpoints.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Reported sensitivity
89.8
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Overall standalone sensitivity; see study context.

Reported specificity
95
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Overall standalone specificity; see study context.

Overall sensitivity

89.8 percent

  • EndpointStandalone suspicious-case classification
  • Population1,019 FFDM and DBT examinations in two retrospective blinded studies
  • Tested versionMammoSightAI
Source

Overall specificity

95 percent

  • EndpointStandalone suspicious-case classification
  • Population1,019 FFDM and DBT examinations in two retrospective blinded studies
  • Tested versionMammoSightAI
Source

MammoSightAI regulatory retrospective blinded studies

  • DesignTwo retrospective blinded standalone studies.
  • Population1,019 exams: 468 FFDM and 551 DBT; women aged 35 years and older.
  • Scopeexact submission
  • Tested versionMammoSightAI
  • Samplen=1019
  • IndependenceIndependence not established

K252954

Reference standard used biopsy/clinical evidence and follow-up categories described in the summary.

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 product version
  • Checked 2026-09-06
Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-06

No applicable payer policy reviewed.

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

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

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
2026-09-06Last searched
24Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

No stored literature or trial candidates; empty metadata snapshots were screened. 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, acr ai central product, fda decision summary, vendor product page, 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. K252954 FDA decision source

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. MammoSightAI model card (K252954)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. MammoSightAI: K252954 clearance and 510(k) summary

    US Food and Drug Administration - Accessed 2026-09-05

    Scope: identity, clinical, implementation, evidence

  8. SaveLife.AI AI Suite

    SaveLife.AI - Accessed 2026-09-05

    Scope: product_family_implementation

Research history

  1. K252954 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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Provides passive worklist prioritization for compatible FFDM and DBT screening mammograms.

Modality
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