FDA-cleared profile
Canon Medical Systems Corporation
Authorized purpose: Aquilion Precision V8.8 is an ultra-high-resolution whole-body CT system; its AiCE deep-convolutional reconstruction is limited in this clearance to abdomen and pelvis applications and is intended to reduce image noise and improve image quality.
Product overview
Authorized purpose: Aquilion Precision V8.8 is an ultra-high-resolution whole-body CT system; its AiCE deep-convolutional reconstruction is limited in this clearance to abdomen and pelvis applications and is intended to reduce image noise and improve image quality.
Overview status: FDA-bounded overview This overview only restates exact FDA-supported facts. It does not use candidate literature or vendor claims, and it is not a full source or clinician review.
Clinical role: Aquilion Precision V8.8 is an ultra-high-resolution whole-body CT system; its AiCE deep-convolutional reconstruction is limited in this clearance to abdomen and pelvis applications and is intended to reduce image noise and improve image quality.
FDA record boundary: K182901 reports phantom image-quality testing and representative radiologist review. At matched dose, AiCE showed 13% improved low-contrast detectability and 42% noise reduction for super-high-resolution body imaging versus AIDR 3D, with an 8.8 lp/cm high-contrast spatial-resolution claim at 10% MTF.
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.
The exact indication names a trained and qualified physician and does not name CT technologists as an intended-user class.
Previous value withdrawn: The exact FDA decision-summary packet reviewed on 2026-09-19 does not establish this claim.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The exact indication states the AiCE application boundary; the dossier's broader claims about dose reduction, diagnostic accuracy, and patient outcomes are not stated in this packet.
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 packet identifies the device as a computed tomography X-ray system and does not establish the dossier's CTA claim. Controlled directory display reconciled from exact FDA wording: Computed Tomography (CT) -> CT/CTA.
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 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. Candidate literature without exact product and version linkage is not shown as product evidence.
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.
13 %
42 %
8.8 lp/cm
K182901
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
Costs and setup
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 packet assessed on 2026-09-19. Directory-backed facts were reconciled only where purpose, modality, and anatomy were each directly established. Candidate literature and postmarket candidates remain in their existing review state. 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, fda decision summary packet, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, anatomy, output, evidenceSummary, modality, intendedUsers, limitations, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: productFamily, workflowRole, implementationCapabilities, currentCommercialContext
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Exact FDA fact-bound editorial overlay; not a source or clinician review
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