FDA-cleared profile
Hutom Inc.
Authorized purpose: RUS processes CT images for trained professionals using organ and vessel segmentation, pneumoperitoneum estimation, measurements, paths, and two- or three-dimensional visualization to support reporting and treatment or surgical planning.
Product overview
Authorized purpose: RUS processes CT images for trained professionals using organ and vessel segmentation, pneumoperitoneum estimation, measurements, paths, and two- or three-dimensional visualization to support reporting and treatment or surgical planning.
Overview status: Source-reviewed overview
Clinical role: RUS processes CT images for trained professionals using organ and vessel segmentation, pneumoperitoneum estimation, measurements, paths, and two- or three-dimensional visualization to support reporting and treatment or surgical planning.
Evidence from the reviewed source record: Exact-submission testing used 60 patient CT studies with institution-level separation. Organ and vessel Dice and pneumoperitoneum error met prespecified targets. A 2026 prospective multicenter lung-segmentectomy study adds product-family implementation evidence.
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.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The exact text supports these visualization, segmentation, path, measurement, reporting, and pneumoperitoneum functions but does not mention airway output.
The exact packet directly states the mammography exclusion, auxiliary surgical-planning role, and clinician responsibility; the current product-family lung-surgery sentence is not in the 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 indication specifies iodine contrast-enhanced abdomen CT and does not establish the broader CT/CTA value. Controlled directory display reconciled from exact FDA wording: Iodine contrast-enhanced abdomen CT. -> CT/CTA.
The exact packet specifies abdomen CT and names abdominal organs and vascular structures; it does not establish a chest scope. Controlled directory display reconciled from exact FDA wording: Abdomen (including liver, stomach, spleen, gallbladder, pancreas, and vessels). -> Chest/Abdomen.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request data-flow, identity, audit, encryption, retention, support-access, vulnerability-management, backup, and incident-response evidence.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K233457 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Windows PC software with DICOM SCP/SCU functions and 2D/3D visualization and reporting.
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. RUS is CT-only in K233457. Three models have distinct endpoints, and all automated outputs require professional review. Current lung-surgery research is product-family clinical evidence, not exact-release validation.
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: RUS is CT-only in K233457. Three models have distinct endpoints, and all automated outputs require professional review. Current lung-surgery research is product-family clinical evidence, not exact-release validation.
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 dose-delivery 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 dose-delivery function. Use the task-specific endpoints and tested population reported below.
0.927 DSC
0.92 DSC
0.972 mm
K233457
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
DOI 10.3389/fonc.2026.1774607
Product-family implementation evidence; abstract exact outcomes before publishing numerical claims.
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.
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. 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, vendor product page, peer reviewed publication, reimbursement policy, fda device recall, 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, intendedUsers, input, modality, anatomy, output, limitations, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: productFamily, workflowRole, integration, deployment, implementationCapabilities, currentCommercialContext
Scope: limitations, evidenceSummary, evidenceStudy, implementationCapabilities, monitoring
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
Alternatives
Agada Medical, Ltd.
Auto-Seg and Spine Auto-Seg accept spine and pelvis CT images and provide three-dimensional segmentation and labels to support spine-surgery planning and assessment by spine...
Brainomix Limited
Provides volumetric hyperdensity segmentation and quantification as an aid; physicians must review original images.
Mighty Oak Medical
Acorn 3D Software and Acorn 3DP Model process CT, synthetic CT, and CT angiography for segmentation, visualization, measurement, treatment planning, and three-dimensional...
Keya Medical Technology Co., Ltd.
Coronary plaque and stenosis quantification from CCTA