Supported acquisition environment
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
FDA-cleared profile
Clarius AI
Clarius Mobile Health Corp.
Authorized purpose: Semi-automatic caliper placement for non-invasive musculoskeletal tendon-thickness measurements on ultrasound data.
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: Semi-automatic caliper placement for non-invasive musculoskeletal tendon-thickness measurements on ultrasound data.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Semi-automatic caliper placement for non-invasive musculoskeletal tendon-thickness measurements on ultrasound data.
- Which images or clinical context are in scope? Modality: Ultrasound Anatomy or clinical context: Plantar fascia/foot, Achilles tendon/ankle, and patellar tendon/knee. Input: Real-time ultrasound data acquired by the Clarius Ultrasound Scanner using the L7 or L15 transducer; adult patients only.
- Who uses it? Intended users: Healthcare professionals trained and qualified in musculoskeletal ultrasound.
- What does the software produce? Output: Tendon segmentation overlay, adjustable calipers at the thickest region, and tendon thickness in millimeters.
- What is its most important limitation? Key limitation: Adults only and compatible Clarius scanner/transducer scope; users may manually adjust calipers, retain measurement responsibility, and must not treat the device as a replacement for clinical decision-making.
Clinical takeaway
Clinical role: Semi-automatic caliper placement for non-invasive musculoskeletal tendon-thickness measurements on ultrasound data.
Evidence takeaway
Evidence from the reviewed source record: FDA packet reports 20,287 images used for model development and validation on 73 subjects with 2,503 ultrasound images/frames; average Dice was 96% and mean IoU was 94%.
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
- Semi-automatic caliper placement for non-invasive musculoskeletal tendon-thickness measurements on ultrasound data.
Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.
- Intended users
- Healthcare professionals trained and qualified in musculoskeletal ultrasound.
Exact FDA indications-for-use user statement.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Measurement or quantification
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- Real-time ultrasound data acquired by the Clarius Ultrasound Scanner using the L7 or L15 transducer; adult patients only.
FDA device description and indications.
- Output and human action
- Tendon segmentation overlay, adjustable calipers at the thickest region, and tendon thickness in millimeters.
FDA device description output scope.
- Limitations
- Adults only and compatible Clarius scanner/transducer scope; users may manually adjust calipers, retain measurement responsibility, and must not treat the device as a replacement for clinical decision-making.
Exact FDA indication and device-description boundary.
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
- K222406
- Modality
- Ultrasound
FDA musculoskeletal ultrasound scope.
- Anatomy
- Plantar fascia/foot, Achilles tendon/ankle, and patellar tendon/knee.
Exact FDA examples of supported musculoskeletal structures.
- Clearance type
- 510(k)
- Decision date
- 2023-01-23
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
- Deployment and data flow
- On-cloud
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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
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 AI; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Evidence
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 packet reports 20,287 images used for model development and validation on 73 subjects with 2,503 ultrasound images/frames; average Dice was 96% and mean IoU was 94%.
Submission-reported model verification/validation evidence.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
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 AI regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K222406
- Samplen=73
- IndependenceIndependence not established
K222406
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
No public price or quote for the exact K222406 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K222406. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K222406 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
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
10Source 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 device recall, literature index, trial registry, fda decision summary packet, 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
-
FDA K222406: Clarius AI
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Clarius AI model card (K222406)
Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K222406
Scope: postmarketSafety
Research history
-
K222406 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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