Radiology AI Directory

FDA-cleared profile

QOCA image Smart CXR Image Processing System

Quanta Computer Inc.

Authorized purpose: QOCA image Smart CXR analyzes adult chest X-ray images and flags cases with suspected pneumothorax to support prioritization for radiologist review.

Acute 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: QOCA image Smart CXR analyzes adult chest X-ray images and flags cases with suspected pneumothorax to support prioritization for radiologist review.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: QOCA image Smart CXR analyzes adult chest X-ray images and flags cases with suspected pneumothorax to support prioritization for radiologist review.

Evidence takeaway

Evidence from the reviewed source record: The performance of the subject device, QOCA® image Smart CXR Image Processing System, has been validated in two separate pivotal studies. The performance of the subject device across the performance assessment dataset achieves an area under the curve (AUC) of 97.8% (95% CI: [97.0%, 98.5%]); in addition, the sensitivity and specificity achieves 92.5% (95% CI: [90.5%, 94.2%]), 94.0% (95% CI: [93.9%, 94.6%]) respectively, without subgroup breakdown.

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
QOCA image Smart CXR analyzes adult chest X-ray images and flags cases with suspected pneumothorax to support prioritization for radiologist review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
Radiologists reviewing adult chest radiographs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Care setting and population
Hospital PACS workflow for adult chest radiographs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-14
Workflow role
Passive case-level triage notification within the radiologist worklist; no cases are removed from the standard workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-14
Required input
Adult chest radiographs in PA or AP erect view, received as DICOM files pushed from PACS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Output and human action
A notation beside cases with suspected pneumothorax for radiologist prioritization; it does not directly mark the image location or anomaly.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Limitations
The output is not a substitute for radiologist diagnosis and is not for standalone clinical decision-making. It is limited to PA or AP erect adult chest radiographs and does not directly indicate image locations or anomalies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

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
K221868
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Anatomy
Chest/Lung
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-01-27
  • 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 connects with hospital PACS, analyzes DICOM files pushed from PACS, and presents case-level notations in its viewer. Exact local interface compatibility requires site validation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-14
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-14

Current security controls, data retention, access model, and assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-14

Current training, competency, and support commitments require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-14

Site-specific quality monitoring, update control, escalation, and incident-response commitments require vendor and local governance evidence.

Input and worklist workflow

The FDA packet describes DICOM intake from hospital PACS and passive worklist notation for radiologist review.

exact submission · checked 2026-09-14

Confirm supported PACS versions, routing, and viewer behavior locally.

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
The performance of the subject device, QOCA® image Smart CXR Image Processing System, has been validated in two separate pivotal studies. The performance of the subject device across the performance assessment dataset achieves an area under the curve (AUC) of 97.8% (95% CI: [97.0%, 98.5%]); in addition, the sensitivity and specificity achieves 92.5% (95% CI: [90.5%, 94.2%]), 94.0% (95% CI: [93.9%, 94.6%]) respectively, without subgroup breakdown.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The replacement uses the packet's pivotal-study and aggregate performance results without adding an independent-outcome characterization.

Reported sensitivity
92.5% (95% CI: 90.5%, 94.2%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
94.0% (95% CI: 93.9%, 94.6%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

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.

QOCA image Smart CXR Image Processing System regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K221868
  • Samplen=6052
  • IndependenceIndependence not established

K221868

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 2026-09-14

No current exact-product price, contract term, or implementation fee was established.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-14

No exact-product payer policy, coding instruction, or payment determination was established.

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
Candidate records await review
  • Human review pending
  • Exact FDA submission
  • Checked 2026-09-14

Exact-submission postmarket candidates remain quarantined pending a separate source review.

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
28Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. 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, fda decision summary, acr ai central product, fda decision summary packet, 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. K221868 FDA 510(k) decision summary

    U.S. Food and Drug Administration - Published 2023-01-27 - Accessed 2026-09-19

    Scope: purpose, modality, anatomy, intendedUsers, workflowRole, input, output, careSetting, limitations, evidenceSummary, integration, clinicalUse

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. QOCA image Smart CXR Image Processing System model card (K221868)

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

    Scope: intendedUsers, careSetting, output, limitations, 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

Research history

  1. K221868 FDA decision

    Regulatory record

    510(k)

  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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