Radiology AI Directory

FDA-cleared profile

Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)

Agada Medical, Ltd.

Authorized purpose: 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 surgeons.

MSK and boneQuantification and segmentation
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: 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 surgeons.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: 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 surgeons.

Evidence takeaway

Evidence from the reviewed source record: The exact FDA decision material describes the labeled intended use and submission-level verification for this release. It does not establish a product-wide clinical sensitivity or specificity claim or independent clinical outcome evidence.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
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 surgeons.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Spine surgeons and the relevant surgical team.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Professional healthcare, procedural, surgical, or clinical point-of-care settings within the labeled use.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
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 surgeons.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
The exact submission's labeled medical-image, measurement, or clinical-workflow inputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Visualizations, segmentations, measurements, reconstructions, planning information, or other software outputs described in the exact FDA labeling.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The FDA material states that the software does not diagnose, recommend treatment, or select implants; use is limited to the labeled adult spine-surgery workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K253628
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Spine
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-06-29
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Imports spine and pelvis CT studies as DICOM from an encrypted USB workflow and exports results to encrypted USB; local round-trip acceptance remains necessary.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Deployment and data flow
A standard PC with GPU in an office environment is described; hosting, availability, and service terms are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Security controls, hosting boundaries, audit behavior, identity management, and incident commitments for the exact configuration are not established in the public FDA decision material.

Training and support
Use by the qualified healthcare professionals identified for the exact labeled workflow; site-specific competency and training requirements remain to be established locally.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-04

Post-deployment monitoring, drift thresholds, alerting, and revalidation commitments for the exact configuration require vendor and site confirmation.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K253628 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

Imports spine and pelvis CT studies as DICOM from an encrypted USB workflow and exports results to encrypted USB; local round-trip acceptance remains necessary.

exact submission · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source

Clinical acceptance

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. The FDA material states that the software does not diagnose, recommend treatment, or select implants; use is limited to the labeled adult spine-surgery workflow.

exact submission · checked 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

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 2026-09-04

No exact-product price was found in the evidence set; productivity or value claims require local evidence.

Source

Lifecycle monitoring

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes; exact monitoring thresholds and vendor commitments are unknown.

exact submission · checked 2026-09-04

Establish ownership for data quality, overrides, drift, incidents, recalls, and change control.

Source

Evidence

Performance 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.

Evidence summary
The exact FDA decision material describes the labeled intended use and submission-level verification for this release. It does not establish a product-wide clinical sensitivity or specificity claim or independent clinical outcome evidence.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-product, version-specific sensitivity endpoint was established for this submission in the evidence set.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-product, version-specific specificity endpoint was established for this submission in the evidence set.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K253628 FDA evidence package for Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)

  • DesignFDA submission-level decision material with device, software, performance, safety, and/or usability verification as applicable; not independent clinical validation.
  • PopulationPopulation and workflow are limited to the exact FDA labeling summarized for this submission.
  • Scopeexact submission
  • Tested versionExact FDA submission release; version not separately stated in the public decision material
  • IndependenceSponsor or vendor study

K253628

Evidence submitted for the exact FDA decision is not independent clinical validation. Local technical, clinical, privacy, security, and workflow acceptance remains necessary.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No public list price for the exact cleared configuration was found in the evidence set. Obtain a written quote covering license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, downtime, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, dental, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-04

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Reviewed CMS material is not a product-specific price or coverage determination; do not infer reimbursement from FDA clearance.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K253628 by native exact submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-19Last searched
27Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 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 material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA 510(k) decision material K253628: Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)

    U.S. Food and Drug Administration - Published 2026-06-29 - Accessed 2026-09-04

    Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K253628 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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