Authorized purpose: Clarius Prostate AI provides semi-automatic measurements of prostate volume from ultrasound data acquired by the Clarius Ultrasound Scanner.
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: Clarius Prostate AI provides semi-automatic measurements of prostate volume from ultrasound data acquired by the Clarius Ultrasound Scanner.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Clarius Prostate AI provides semi-automatic measurements of prostate volume from ultrasound data acquired by the Clarius Ultrasound Scanner.
Which images or clinical context are in scope?Modality: Ultrasound Anatomy or clinical context: Prostate Input: B-mode prostate ultrasound data acquired with Clarius C3 HD3 or EC7 HD3 curvilinear or endo-cavitary scanners through the Clarius App.
Who uses it?Intended users: Healthcare professionals trained and qualified in ultrasound.
What does the software produce?Output: Automatic prostate length, width, and height measurements, corresponding-view detection, segmentation, adjustable caliper placement, and calculated prostate volume.
What is its most important limitation?Key limitation: Limited to adult male patients, B-mode use, and the named Clarius scanner and transducer configurations. It is not standalone software, does not replace clinical decision-making, and the user must confirm measurements using standard practice and clinical judgment.
Clinical takeaway
Clinical role: Clarius Prostate AI provides semi-automatic measurements of prostate volume from ultrasound data acquired by the Clarius Ultrasound Scanner.
Evidence takeaway
Evidence from the reviewed source record: The FDA summary reports a retrospective, multicenter clinical-verification study of 139 male subjects, separate from model training and tuning. It reports 95% view-prediction accuracy and ICC values of 0.87 for endo-cavitary and 0.67 for curvilinear probes. These are manufacturer regulatory-study results, not independent clinical-outcome evidence.
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
Clarius Prostate AI provides semi-automatic measurements of prostate volume from ultrasound data acquired by the Clarius Ultrasound Scanner.
FDA source
Exact FDA submission
Checked 2026-09-19
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
Limited to adult male patients, B-mode use, and the named Clarius scanner and transducer configurations. It is not standalone software, does not replace clinical decision-making, and the user must confirm measurements using standard practice and clinical judgment.
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.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
Clarius Prostate AI is integrated into the Clarius App for iOS and Android and operates with the named Clarius Ultrasound Scanner configurations; it is not standalone software. Local downstream interface compatibility is not established by the FDA packet.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
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.
Integrated acquisition workflow
The FDA packet describes integration with the Clarius App and C3 HD3 or EC7 HD3 Clarius Ultrasound Scanner configurations for B-mode prostate ultrasound.
exact submission ยท checked 2026-09-14
Confirm current mobile operating-system support, configurations, and downstream interfaces locally.
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 FDA summary reports a retrospective, multicenter clinical-verification study of 139 male subjects, separate from model training and tuning. It reports 95% view-prediction accuracy and ICC values of 0.87 for endo-cavitary and 0.67 for curvilinear probes. These are manufacturer regulatory-study results, not independent clinical-outcome evidence.
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.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Clarius Prostate AI regulatory performance study summary
DesignStand-Alone Performance
PopulationAdult
Scopeexact submission
Tested versionExact product version not reported; regulatory study summarized for FDA submission K243853
Samplen=139
IndependenceIndependence not established
K243853
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
Verify security and privacy controls: Current security controls, data retention, access model, and assurance documentation require vendor confirmation.
Verify training: Current training, competency, and support commitments require vendor confirmation.
Verify pricing and total cost: No current exact-product price, contract term, or implementation fee was established.
Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established.
Verify local validation and lifecycle monitoring: Site-specific quality monitoring, update control, escalation, and incident-response commitments require vendor and local governance evidence.
Verify recalls and postmarket safety signals: Exact-submission postmarket candidates remain quarantined pending a separate source review.
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
24Fields 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 history6 sources - 3 history items
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