Radiology AI Directory

FDA-cleared profile

DeepCT

Deep01 Limited

Authorized purpose: Notification-only, parallel-workflow triage that identifies and communicates acute non-contrast brain CT studies with suspected ICH to a specialist for image review; not for diagnosis beyond notification.

Stroke and ICH triageAcute 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: Notification-only, parallel-workflow triage that identifies and communicates acute non-contrast brain CT studies with suspected ICH to a specialist for image review; not for diagnosis beyond notification.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Notification-only, parallel-workflow triage that identifies and communicates acute non-contrast brain CT studies with suspected ICH to a specialist for image review; not for diagnosis beyond notification.

Evidence takeaway

Evidence from the reviewed source record: Retrospective multicenter, multinational performance study: 260 cases from 5 sites (2 US and 3 OUS), with approximately equal ICH-positive and ICH-negative cases. FDA reports sensitivity 93.8% (95% CI 88.3%-96.8%) and specificity 92.3% (95% CI 86.4%-95.7%), both exceeding an 80% goal. Processing time was measured in 122 cases at 30.6 seconds (95% CI 25.8-35.4 seconds); latency is distinct from the diagnostic 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
Notification-only, parallel-workflow triage that identifies and communicates acute non-contrast brain CT studies with suspected ICH to a specialist for image review; not for diagnosis beyond notification.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Hospital networks and trained clinicians; notified medical specialists in hospital emergency-room settings.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Acute hospital emergency-room workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Parallel AI triage and notification independent of standard-of-care image interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
DICOM series of acute non-contrast CT images of the brain from patients suspected of ICH and/or hematoma.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Binary ICH-present/ICH-absent interpretation result and a notification or text message identifying the study for specialist review; no other diagnostic information is generated.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Identification is not for diagnostic use beyond notification. Clinicians must view the complete CT on a diagnostic viewer, perform full patient evaluation, and discuss care with a treating specialist; DeepCT must not be used in lieu of evaluation or to make or confirm a diagnosis.
  • 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
K182875
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Brain, for suspected intracranial hemorrhage and/or hematoma.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2019-07-10
  • 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
Software-only device with hospital-configured Image Forwarding Software and an Image Processing and Analysis Server; a copy of local DICOM files is sent for analysis, the result is shown on screen, and suspected ICH triggers specialist notification. The packet does not establish a specific local PACS/RIS/EHR interface.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
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 2026-09-09

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.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

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 DeepCT; 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
Retrospective multicenter, multinational performance study: 260 cases from 5 sites (2 US and 3 OUS), with approximately equal ICH-positive and ICH-negative cases. FDA reports sensitivity 93.8% (95% CI 88.3%-96.8%) and specificity 92.3% (95% CI 86.4%-95.7%), both exceeding an 80% goal. Processing time was measured in 122 cases at 30.6 seconds (95% CI 25.8-35.4 seconds); latency is distinct from the diagnostic endpoints.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
93.8% (95% CI: 88.3%-96.8%) for identifying non-contrast CT head images containing ICH in a 260-case, 5-site retrospective study; exceeded the 80% performance goal.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

Bounds the sensitivity to the FDA ICH-detection endpoint; 96.8% is the upper sensitivity confidence bound, not a specificity value.

Reported specificity
92.3% (95% CI: 86.4%-95.7%) for identifying non-contrast CT head images containing ICH in the same 260-case, 5-site retrospective study; exceeded the 80% performance goal.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

Corrects the active-directory conflation of the 80% goal and the 96.8% sensitivity confidence bound; FDA specificity is 92.3% with its own confidence interval.

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

DeepCT regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K182875
  • Samplen=260
  • Sites5
  • IndependenceIndependence not established

K182875

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 K182875 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 K182875. 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
2026-09-20Last searched
25Fields reviewed
9Source classes checked
8Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 8 PubMed and 0 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 8 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 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 K182875: DeepCT

    U.S. Food and Drug Administration - Published 2019-07-10 - 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. DeepCT model card (K182875)

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

    Scope: intendedUsers, 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

  7. openFDA exact recall query for K182875

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

    Scope: postmarketSafety

Research history

  1. K182875 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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