Radiology AI Directory

FDA-cleared profile

CLEARREAD +CONFIRM

RIVERAIN TECHNOLOGIES

Generation of an enhanced secondary chest radiograph to facilitate confirmation and localization of lines and tubes; adjunctive information, not a substitute for the original image.

Cardiac imaging
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

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
Generation of an enhanced secondary chest radiograph to facilitate confirmation and localization of lines and tubes; adjunctive information, not a substitute for the original image.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Trained professionals such as physicians, radiologists, and technicians
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
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
Post-processing image enhancement for adjunctive line, tube, and electrical-cardiac-wire confirmation and localization.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
AP or PA chest radiographs from patients with lines and tubes; the device is not intended for pediatric patients.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
An enhanced secondary digital AP/PA chest radiographic image with improved visibility of lines and tubes, including tube, line, and electrical cardiac-wire tips, for adjunctive confirmation; the original image remains required.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The enhanced image is not a substitute for the original AP/PA image and provides adjunctive rather than diagnostic information. It is not intended for pediatric patients and is limited to chest radiographs of patients with lines and tubes; the packet does not establish a sensitivity or specificity endpoint.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K123526
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Chest, including lines, tubes, and electrical cardiac wires
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2012-12-27
  • 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
The device shares a DICOM communication and system-configuration platform with ClearRead Bone Suppression and supports review, storage, printing, and distribution of DICOM-compliant images across hospital networks. A specific PACS/RIS interface or deployment model is not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for CLEARREAD +CONFIRM; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
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
Functional verification and development validation tested the software against design requirements. A multi-reader, multi-case clinical validation measured radiologist time to localize tube, line, and electrical cardiac-wire tips and localization accuracy; ClearRead +Confirm significantly decreased read times with and without outliers, while differences from true locations were not statistically significant. No numeric sensitivity, specificity, or AUC endpoint is reported.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

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

ClearRead +Confirm regulatory performance study summary

  • DesignReader Study
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K123526
  • IndependenceIndependence not established

K123526

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

No public price or quote for the exact K123526 configuration was established in this review.

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

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 K123526. 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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

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
2026-09-09Last searched
21Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
1Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 1 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, acr ai central product, fda decision summary, 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 K123526: CLEARREAD +CONFIRM

    U.S. Food and Drug Administration - Published 2012-12-27 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. ClearRead +Confirm model card (K123526)

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

    Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, 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. openFDA exact recall query for K123526

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

    Scope: postmarketSafety

Research history

  1. K123526 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

Alternatives

Related tools to compare

FDA-cleared K251934

qXR-Detect

Qure.Ai Technologies

qXR-Detect is an adult chest-radiograph concurrent reading aid that identifies, highlights and categorizes suspicious regions of interest across lung, pleura,...

Modality
X-ray/Radiography
Anatomy
Chest/Lung; pleura, mediastinum/hila/heart, bone, hardware and other chest-radiograph regions
Decision
2026-01-16
Cardiac imagingMSK and boneDetection and CADe
FDA-cleared K231001

DeepTek CXR Analyzer v1.0

DeepTek Medical Imaging Pvt Ltd

Concurrent CADe support for identifying, categorizing, and highlighting suspicious regions of interest in the Lungs, Pleura, Cardiac, and Hardware categories on chest radiographs...

Modality
X-ray/Radiography
Anatomy
Chest: lungs, pleura, cardiac structures, and hardware
Decision
2023-10-05
Cardiac imagingDetection and CADe
FDA-cleared K231149

qXR-CTR

Qure.ai Technologies

Automated measurement of cardiac diameter, thoracic diameter, and the cardiothoracic ratio (CTR) on posterior-anterior chest X-rays to aid physicians or licensed practitioners;...

Modality
X-ray/Radiography
Anatomy
Heart and thoracic cavity
Decision
2023-09-22
Cardiac imagingQuantification and segmentation
FDA-cleared K222036

MPXA-2000

Medipixel, Inc.

Quantified results from X-ray angiographic images of the coronary arteries to support clinical decisions about diagnosis or treatment evaluation in adult patients with coronary...

Modality
X-ray/Radiography
Anatomy
Coronary arteries and cardiovascular anatomy
Decision
2023-03-22
Cardiac imagingQuantification and segmentation