FDA-cleared profile
Canon Medical Systems Corporation
Authorized purpose: Aplio i900/i800/i700 software V6.5 is a mobile diagnostic ultrasound system for trained physicians or legally qualified users to visualize structures and dynamic processes and provide diagnostic images across fetal, abdominal, pediatric, small-organ, cephalic, cardiac, vascular, transesophageal, musculoskeletal, laparoscopic, and thoracic or pleural applications using B-mode, Doppler, elastography, and related ultrasound modes.
Product overview
Authorized purpose: Aplio i900/i800/i700 software V6.5 is a mobile diagnostic ultrasound system for trained physicians or legally qualified users to visualize structures and dynamic processes and provide diagnostic images across fetal, abdominal, pediatric, small-organ, cephalic, cardiac, vascular, transesophageal, musculoskeletal, laparoscopic, and thoracic or pleural applications using B-mode, Doppler, elastography, and related ultrasound modes.
Overview status: Source-reviewed overview
Clinical role: Aplio i900/i800/i700 software V6.5 is a mobile diagnostic ultrasound system for trained physicians or legally qualified users to visualize structures and dynamic processes and provide diagnostic images across fetal, abdominal, pediatric, small-organ, cephalic, cardiac, vascular, transesophageal, musculoskeletal, laparoscopic, and thoracic or pleural applications using B-mode, Doppler, elastography, and related ultrasound modes.
Evidence from the reviewed source record: FDA-reviewed support consists of manufacturer verification and validation with phantoms, test data, and volunteer data. No independent clinical outcomes study is reported in the 510(k) summary.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The exact packet establishes the mobile systems and probe/frequency scope; it does not establish the dossier's stored-raw-data and external-connection input wording.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The direct packet establishes the user/setting boundary and testing boundary without the dossier's configuration-dependent limitation.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
The exact device name and common name identify a diagnostic ultrasound system; the active dossier has no modality fact. Controlled directory display reconciled from exact FDA wording: Diagnostic Ultrasound System. -> Ultrasound.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Confirm the installed IHE statement, DICOM services, network-storage configuration, deidentification behavior, and cloud transfer terms for the exact local software build.
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Supports compatible linear, convex, and sector probes at approximately 2 to 30 MHz and B-mode, M-mode, continuous-wave, color, pulsed-wave, power and combination Doppler, tissue harmonic, shear-wave, elastography, attenuation, and related modes.
exact submission · checked 2026-09-02Confirm each probe, option, and clinical preset on the purchased configuration.
The FDA summary describes DICOM transfer through Tricefy Access, raw-data storage on network-attached storage, and deidentified image sharing through Apligate or Apligate Soft.
exact submission · checked 2026-09-02Validate local routing, firewall rules, identity handling, storage capacity, retention, and external-service terms before use.
Canon's current interoperability page lists IHE integration statements for Aplio i700, i800, and i900 software V6.0 or later.
exact product version · checked 2026-09-02Obtain and test the statement corresponding to the exact installed model and software build.
Mobile, on-premises diagnostic ultrasound console with optional site-network and external-service connectivity.
exact submission · checked 2026-09-02Site preparation, cybersecurity controls, service access, software-update policy, training, and downtime planning require current vendor documentation.
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.
This field has not been curated yet.
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.
K212333
Regulatory verification and validation evidence; it does not establish comparative clinical outcomes or site-specific performance.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.
Open, Classified
2022-11-08Exact i-series model match. The FDA recall record does not identify software V6.5 and also includes Aplio a-series models, so confirm the affected system and version locally.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains 20 PubMed and 10 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 20 PubMed and 10 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. 1 FDA recall candidate was manually reviewed: 1 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 1 postmarket candidate record; 1 has been reviewed (1 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, fda device recall, vendor interoperability, fda decision summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, anatomy, intendedUsers, output, modality, input, limitations, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: integration, implementationCapabilities
Regulatory record
510(k)
Research record
human reviewed
Editorial review
Source-reviewed editorial overlay
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