FDA-cleared profile
Canon Medical Systems Corporation
Aquilion Precision is an ultra-high-resolution whole-body CT system; AiCE deep-convolutional reconstruction reduces noise and improves image quality for abdomen and pelvis applications.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
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.
Confirm the controls against the exact contracted architecture and release.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K182901 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Installed scanner reconstruction and DICOM workflow; validate protocol, matrix, reconstruction label, quantitative values, PACS presentation, and downstream compatibility.
exact submission · checked 2026-09-03Test 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. AiCE is limited in K182901 to abdomen and pelvis, despite whole-body use of other reconstruction methods. Reported phantom improvements at matched dose do not establish dose reduction, diagnostic accuracy, or patient outcomes for every protocol.
exact submission · checked 2026-09-03Define 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 2026-09-03Vendor productivity claims are scenario inputs, not guaranteed local savings.
Monitor by exact hardware, software and model 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. Track the limits that matter for this product: AiCE is limited in K182901 to abdomen and pelvis, despite whole-body use of other reconstruction methods. Reported phantom improvements at matched dose do not establish dose reduction, diagnostic accuracy, or patient outcomes for every protocol.
exact submission · checked 2026-09-03Revalidate 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 the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.
Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.
AiCE versus AIDR 3D at matched dose in Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE.
Tested version: Aquilion Precision TSX-304A/1 and /2 V8.8 with AiCESuper-high-resolution body AiCE versus AIDR 3D at matched dose in Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE.
Tested version: Aquilion Precision TSX-304A/1 and /2 V8.8 with AiCE10% modulation transfer function for abdomen/body in Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE.
Tested version: Aquilion Precision TSX-304A/1 and /2 V8.8 with AiCEManufacturer phantom image-quality evaluation and board-certified radiologist review of representative abdomen and pelvis images · Abdomen and pelvis CT protocols on Aquilion Precision V8.8
exact submission · Tested version: Aquilion Precision TSX-304A/1 and /2 V8.8 with AiCE · Sponsor or vendor studyK182901
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
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, enabled features, 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 StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA materials, current product-family sources, selected clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 20 PubMed and 10 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, vendor product page, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-03.
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