Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
Red Dot
Behold.AI Technologies Limited
Authorized purpose: The red dot software platform is a software workflow tool designed to aid the clinical assessment of adult chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. Red dot analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. red dot is not intended to direct attention to specific portions basis for clinical decision-making nor is it intended to rule out Pneumothorax or otherwise preclude clinical assessment of X-Ray cases.
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 red dot software platform is a software workflow tool designed to aid the clinical assessment of adult chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. Red dot analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. red dot is not intended to direct attention to specific portions basis for clinical decision-making nor is it intended to rule out Pneumothorax or otherwise preclude clinical assessment of X-Ray cases.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: The red dot software platform is a software workflow tool designed to aid the clinical assessment of adult chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. Red dot analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. red dot is not intended to direct attention to specific portions basis for clinical decision-making nor is it intended to rule out Pneumothorax or otherwise preclude clinical assessment of X-Ray cases.
- Which images or clinical context are in scope? Modality: X-ray/Radiography Anatomy or clinical context: Chest/Lung Input: PA/AP chest x-rays
- Who uses it? Intended users: Radiologist
- What does the software produce? Output: The device provides a case-level passive notification/flag to the PACS/RIS/workstation worklist indicating the existence of a chest X-ray case that may potentially benefit from prioritization due to features suggestive of pneumothorax. It does not output an image, does not mark or highlight specific locations, and does not provide a definitive diagnosis.
- What is its most important limitation? Key limitation: red dot™ is not intended to direct attention to specific portions of an image or to anomalies other than Pneumothorax. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out Pneumothorax or otherwise preclude clinical assessment of X-Ray cases.
Clinical takeaway
Clinical role: The red dot software platform is a software workflow tool designed to aid the clinical assessment of adult chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. Red dot analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. red dot is not intended to direct attention to specific portions basis for clinical decision-making nor is it intended to rule out Pneumothorax or otherwise preclude clinical assessment of X-Ray cases.
Evidence takeaway
Evidence from the reviewed source record: Study type: Stand-Alone Performance. Cases: 888. Sites: 4. Reference standard: Interpretation by Reviewing Clinician. Reported sensitivity: 94.65% (95% CI: 91.46%, 96.91%). Reported specificity: 87.95% (95% CI: 85.04%, 90.46%). Reported accuracy: 90.20 % ( 88.06-92.08)
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 red dot software platform is a software workflow tool designed to aid the clinical assessment of adult chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. Red dot analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. red dot is not intended to direct attention to specific portions basis for clinical decision-making nor is it intended to rule out Pneumothorax or otherwise preclude clinical assessment of X-Ray cases.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
- Intended users
- Radiologist
The exact packet identifies the user population as Radiologist.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Triage or notification support
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- PA/AP chest x-rays
The exact device description identifies the analyzed images as PA/AP chest x-rays.
- Output and human action
- The device provides a case-level passive notification/flag to the PACS/RIS/workstation worklist indicating the existence of a chest X-ray case that may potentially benefit from prioritization due to features suggestive of pneumothorax. It does not output an image, does not mark or highlight specific locations, and does not provide a definitive diagnosis.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Limitations
- red dot™ is not intended to direct attention to specific portions of an image or to anomalies other than Pneumothorax. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out Pneumothorax or otherwise preclude clinical assessment of X-Ray cases.
The exact indication states the output-use, diagnostic-decision, and clinical-assessment limits.
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
- K191556
- Modality
- X-ray/Radiography
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Anatomy
- Chest/Lung
The exact comparison table identifies the body part as Chest. Controlled directory display reconciled from exact FDA wording: Chest -> Chest/Lung.
- Clearance type
- 510(k)
- Decision date
- 2020-02-28
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The exact-submission ACR model card explicitly references DICOM, PACS, and RIS in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.
- Deployment and data flow
- On-premise
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Result destination
PACS and workstation are explicitly referenced as a result destination.
exact submission · checked 2026-09-01Confirm supported products, versions, routing behavior, and display requirements during local evaluation.
Supported acquisition environment
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Red Dot; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
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
- Study type: Stand-Alone Performance. Cases: 888. Sites: 4. Reference standard: Interpretation by Reviewing Clinician. Reported sensitivity: 94.65% (95% CI: 91.46%, 96.91%). Reported specificity: 87.95% (95% CI: 85.04%, 90.46%). Reported accuracy: 90.20 % ( 88.06-92.08)
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Reported sensitivity
- 94.65% (95% CI: 91.46%, 96.91%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 87.95% (95% CI: 85.04%, 90.46%)
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
red dot regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K191556
- Samplen=888
- Sites4
- IndependenceIndependence not established
K191556
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
- Vendor documentation pending
No public price or quote for the exact K191556 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
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 exact-identifier FDA recall query returned no native recall record for K191556. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K191556 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
28Fields reviewed
10Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 20 PubMed and 10 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 10 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 summary, acr ai central product, fda device recall, literature index, trial registry, fda decision summary packet, 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
-
FDA K191556: Red Dot
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, output, evidenceSummary, intendedUsers, input, limitations
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
red dot model card (K191556)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K191556
Scope: postmarketSafety
Research history
-
K191556 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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