Radiology AI Directory

FDA-cleared profile

Ceevra Reveal 3

Ceevra, Inc.

Ceevra Reveal 3 processes, reviews, analyzes, communicates, and interchanges multidimensional CT and MR images for preoperative planning and intraoperative display, with preliminary machine-learning segmentations of selected normal anatomy for adult patients aged 22 years and older.

Quantification and segmentation
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
Ceevra Reveal 3 processes, reviews, analyzes, communicates, and interchanges multidimensional CT and MR images for preoperative planning and intraoperative display, with preliminary machine-learning segmentations of selected normal anatomy for adult patients aged 22 years and older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Trained radiologists, surgeons, physicians, and other qualified healthcare professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Hospital imaging, surgical-planning, and intraoperative workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Multidimensional image viewing, manipulation, segmentation, planning, and intraoperative display support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported CT and MR DICOM studies and user-selected patient images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Displayed images, reformats, preliminary segmentations, measurements, and planning views.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Machine-learning segmentation is limited to the labeled adult age group and supported models; patients under 22 or of unknown age are outside the stated ML scope, and clinicians make final decisions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

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
K222676
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Radiological images; modality varies or is not specified in FDA list
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Patient-specific anatomy represented in CT or MR; normal anatomy used by supported segmentation models
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-04-25
  • 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 FDA package describes multidimensional CT and MR image input and mobile, desktop, or virtual-reality viewing paths.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is the interface boundary described in the exact FDA package; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.

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

The exact public FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.

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

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only trained radiologists, surgeons, physicians, and other qualified healthcare professionals should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor K222676 by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Machine-learning segmentation is limited to the labeled adult age group and supported models; patients under 22 or of unknown age are outside the stated ML scope, and clinicians make final decisions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Monitoring guidance is buyer-facing implementation guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K222676 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared release includes them.

Source

Deployment boundary

The exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.

exact submission · checked 2026-09-04

FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The FDA package describes multidimensional CT and MR image input and mobile, desktop, or virtual-reality viewing paths.

exact submission · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Machine-learning segmentation is limited to the labeled adult age group and supported models; patients under 22 or of unknown age are outside the stated ML scope, and clinicians make final decisions.

exact submission · checked 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-04

No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.

Source

Lifecycle monitoring

Monitor K222676 by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Machine-learning segmentation is limited to the labeled adult age group and supported models; patients under 22 or of unknown age are outside the stated ML scope, and clinicians make final decisions.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. multimodality medical-image visualization software limits remain submission-specific.

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
K222676 FDA decision material describes the cleared multimodality medical-image visualization software, labeled use, and submission-specific verification. It does not establish product-wide sensitivity, specificity, outcomes, or independent clinical validation for this exact configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.

Prostate segmentation Dice coefficient on MR

0.87 Dice coefficient

  • EndpointNormal-anatomy segmentation agreement
  • PopulationCeevra Reveal 3 MR verification studies
  • Tested versionCeevra Reveal 3 configuration described in K222676
Source

Kidney segmentation Dice coefficient on CT

0.89 Dice coefficient

  • EndpointNormal-anatomy segmentation agreement
  • PopulationCeevra Reveal 3 CT verification studies
  • Tested versionCeevra Reveal 3 configuration described in K222676
Source

K222676 FDA evidence package for Ceevra Reveal 3

  • DesignFDA 510(k) software verification and validation of four machine-learning segmentation models with institution-level separation of development and testing data.
  • PopulationCT and MR imaging studies used to verify the exact Ceevra Reveal 3 segmentation models.
  • Scopeexact submission
  • Tested versionCeevra Reveal 3 configuration described in K222676
  • Samplen=141
  • IndependenceSponsor or vendor study

K222676

The FDA package reports 141 imaging studies and structure-specific Dice or Hausdorff results; preliminary segmentations require clinician review.

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 FDA submission
  • Checked 2026-09-04

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging or clinical service line and verify payer, site-of-service, coding, and coverage assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-04

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This is not a product-specific reimbursement determination. Build a local total-cost and value model and verify payer, site-of-service, coding, and coverage assumptions independently.

Source

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 2026-09-02 openFDA device-recall snapshot contained no record matched to K222676 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals.

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
2026-09-04Last searched
26Fields reviewed
11Source classes checked
0Awaiting review PubMed leads
0Awaiting 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-name and exact-submission searches in the checked 2026-09-01 indexes returned no PubMed records and no ClinicalTrials.gov records for K222676; review status is candidate_review_pending. Literature and registry candidates remain quarantined unless exact submission and tested-version linkage is established. The checked recall disposition is no exact-submission recall record was promoted; ambiguous or family-only candidates are not published. Pricing, complete security architecture, contracted deployment, exact reimbursement, and local interoperability remain unverified. Automated exact-name discovery found 0 PubMed and 0 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, fda decision summary, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, 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 510(k) decision material K222676: Ceevra Reveal 3

    U.S. Food and Drug Administration - Published 2023-04-25 - Accessed 2026-09-04

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

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Ceevra Reveal 3 model card (K222676)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

  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. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K222676 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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