FDA-cleared profile
Canon Medical Systems Corporation
Aplio i900/i800/i700 V7.0 is a mobile diagnostic ultrasound system with supported body and cardiac clinical applications and imaging modes for trained physicians and legally qualified users.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Prior source-backed dossier value: Hospital and clinical environments performing diagnostic ultrasound, including cardiac ultrasound workflows.
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.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
This is the interface boundary described in the exact FDA decision material; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing. Prior source-backed dossier value: The system is an on-premises ultrasound platform with site-network image exchange. Canon's current interoperability page lists an IHE integration statement for Aplio i700, i800, and i900 software V6.0 or later, covering the V7.0 lineage.
This is the release-level boundary described in the exact FDA decision material; current hosting, contracts, security, availability, upgrade path, and site configuration remain separate evidence. Prior source-backed dossier value: On-premises mobile Aplio i900, i800, or i700 ultrasound console running the K241582 software V7.0 configuration.
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.
Buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.
Auto Plane Detection, Quick Strain, Auto LVOT, and Auto AoV automate candidate-view selection, wall-motion-tracking launch, and Doppler waveform tracing; the submission also adds right-ventricular and right-atrial wall-motion tracking.
exact submission · checked 2026-09-02Confirm licensed features, supported probes and presets, user-editing behavior, and report transfer for the purchased configuration.
Mobile Aplio i900, i800, and i700 systems with compatible probes spanning approximately 2 to 33 MHz and standard diagnostic ultrasound imaging modes.
exact submission · checked 2026-09-02Verify exact model, transducer, option, and software-build compatibility.
Canon's current interoperability page lists an IHE integration statement 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 software build.
Mobile, on-premises diagnostic ultrasound console.
exact submission · checked 2026-09-02Site preparation, cybersecurity controls, service access, updates, training, and downtime planning require current vendor documentation.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K241582 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
The FDA material describes a mobile diagnostic ultrasound console; current room, network, archive, service, security, and enabled-option configuration remain unverified.
exact submission · checked 2026-09-04FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.
The FDA material describes the configured ultrasound console, clinical applications, supported probes and modes, and the system's measurement and review workflow.
exact submission · checked 2026-09-04Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
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. Supported applications, probes, modes, patient populations, image quality, and exact system configuration limit use; trained professionals retain responsibility for interpretation.
exact submission · checked 2026-09-04Define stop-use, escalation, rollback, and revalidation triggers before production use.
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 2026-09-04No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.
Monitor K241582 by exact hardware, software, model, 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.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.
Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.
Average pass rate for agreement with sonographer-selected A4C, A3C, A2C, and SAX views; each view was required to exceed 90% agreement in Representative images from 50 U.S. patients selected from 239 patients acquired at one U.S. clinical site.
Tested version: K241582 Auto Plane Detection on Aplio i900, i800, and i700 software V7.0Average reduction in operation time versus conventional three-view wall-motion tracking while meeting ICC and EDV, ESV, EF, and GLS equivalence criteria in Representative images from 50 U.S. patients selected from 239 patients acquired at one U.S. clinical site.
Tested version: K241582 Quick Strain on Aplio i900, i800, and i700 software V7.0Average reduction in operation time for three consecutive heart cycles versus manual LVOT Doppler tracing while meeting ICC and NRMSE criteria in Representative images from 45 U.S. patients selected from 239 patients acquired at one U.S. clinical site.
Tested version: K241582 Auto LVOT on Aplio i900, i800, and i700 software V7.0Average reduction in operation time for three consecutive heart cycles versus manual aortic-valve Doppler tracing while meeting ICC and NRMSE criteria in Representative images from 45 U.S. patients selected from 239 patients acquired at one U.S. clinical site.
Tested version: K241582 Auto AoV on Aplio i900, i800, and i700 software V7.0Manufacturer-sponsored retrospective feature validation using sequestered test images and three licensed sonographers for ground truth · 50 selected patients with ages 20 to 98 years, balanced sex, BMI 16.4 to 71.6 kg/m2, and multiple ejection-fraction severity categories; source pool contained 239 patients from one U.S. site
exact submission · Tested version: K241582 Auto Plane Detection and Quick Strain on software V7.0 · n=50 · 1 site · Sponsor or vendor studyK241582
The test data were independent of training data, but the study was manufacturer-sponsored and did not evaluate patient outcomes.
Manufacturer-sponsored retrospective Doppler-tracing workflow validation using sequestered test images and three licensed sonographers for ground truth · 45 selected patients with ages 36 to 89 years, BMI 18.8 to 71.6 kg/m2, and representative Doppler severity categories; source pool contained 239 patients from one U.S. site
exact submission · Tested version: K241582 Auto LVOT and Auto AoV on software V7.0 · n=45 · 1 site · Sponsor or vendor studyK241582
Age and sex were unavailable for some anonymized cases. The study did not evaluate prospective workflow or patient outcomes.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
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.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesThis is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage assumptions independently.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Screened 20 PubMed and 10 ClinicalTrials.gov records. They concern Aplio i700, i800, or i900 hardware and other ultrasound studies but do not identify the K241582 software V7.0 configuration as tested; all 30 were 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. 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, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, vendor interoperability, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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