Radiology AI Directory

FDA-cleared profile

Clarius Bladder AI

Clarius Mobile Health Corp.

Provide semi-automatic, non-invasive bladder-volume measurements from ultrasound data acquired by the Clarius Ultrasound Scanner using curvilinear or phased-array scanners; a healthcare professional trained and qualified in ultrasound retains responsibility for the measurements, and the device is indicated for adults only.

Quantification and segmentationUltrasound workflow
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
Provide semi-automatic, non-invasive bladder-volume measurements from ultrasound data acquired by the Clarius Ultrasound Scanner using curvilinear or phased-array scanners; a healthcare professional trained and qualified in ultrasound retains responsibility for the measurements, and the device is indicated for adults only.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Licensed healthcare professionals trained and qualified in ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Healthcare setting such as a hospital or clinic; adult patients
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Live or post-capture ultrasound measurement assistance with automatic segmentation and dimension measurement, user-editable calipers, and saved bladder-volume results; it is incorporated into the Clarius App and is not standalone software.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
B-Mode bladder ultrasound data in sagittal and transverse views acquired by the Clarius Ultrasound Scanner using curvilinear or phased-array scanners; the labeled patient population is adults, with the product description naming the Clarius C3 HD3 and PA HD3 transducers and iOS/Android Clarius App.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Automatic bladder depth, width, and height/length measurements, automatic sagittal-versus-transverse view detection, calipers displayed on the image, calculated bladder volume, and user-adjustable measurements; the measurement can be saved with the exam.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Adult patients only, B-Mode bladder imaging only, and compatible Clarius scanner/transducer and Clarius App workflow required. The user may manually adjust measurements and retains ultimate responsibility under standard practices and clinical judgment; the device does not replace clinical decision-making and is not standalone software.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K232257
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Bladder
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-11-13
  • 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 packet establishes incorporation into the Clarius App on iOS and Android, with app support stated as two versions prior to the latest stable release and use with the specified Clarius scanner/transducers. It does not establish DICOM, PACS, RIS, EHR, interface versions, or a current deployment configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

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 2026-09-08

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 2026-09-08

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 2026-09-08

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

ACR exact-submission catalog context

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

exact submission ยท checked 2026-09-08
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
FDA K232257 reports nonclinical verification and validation plus retrospective and prospective clinical performance testing. The retrospective study included 66 subjects aged 31-92, with three expert clinical truthers and a 25% equivalence margin; non-inferiority was reported with p=1.87e-22 and mean difference between percentage differences 0.0548 (95% CI 0.010-0.099). The prospective study included 58 adults aged 21-61, used three qualified reviewers and the same margin, and reported p=1.36e-14 with mean difference -0.0228 (95% CI -0.074-0.028). A clinical validation study confirmed activation, live segmentation, automatic measurements, manual adjustment, and saving results with both scanner types.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
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.

Clarius Bladder AI regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K232257
  • Samplen=66
  • IndependenceIndependence not established

K232257

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 2026-09-08

No public price or quote for the exact K232257 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K232257. 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 2026-09-08

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
2026-09-08Last searched
20Fields reviewed
9Source 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 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 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 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 K232257: Clarius Bladder AI

    U.S. Food and Drug Administration - Published 2023-11-13 - Accessed 2026-09-08

    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. Clarius Bladder AI model card (K232257)

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

    Scope: intendedUsers, careSetting, output, evidenceSummary, anatomy, evidenceStudies

  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 K232257

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K232257 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

Alternatives

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EdgeFlow UW20

Edgecare, Inc.

EdgeFlow UW20 is a wearable ultrasound system for noninvasive periodic bladder-volume measurement in adults with BMI no greater than 30.

Modality
Ultrasound
Anatomy
Urinary bladder
Decision
2026-04-17
Quantification and segmentationUltrasound workflow