Radiology AI Directory

FDA-cleared profile

Segment 3DPrint

Medviso AB

Authorized purpose: Segment 3DPrint reviews and segments images from medical scanners and medical 3D models to generate 3D models for diagnostic visualization, measurement, treatment planning, and additive-manufacturing support in pediatric and adult orthopedic, maxillofacial, and cardiovascular workflows.

Quantification 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: Segment 3DPrint reviews and segments images from medical scanners and medical 3D models to generate 3D models for diagnostic visualization, measurement, treatment planning, and additive-manufacturing support in pediatric and adult orthopedic, maxillofacial, and cardiovascular workflows.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Segment 3DPrint reviews and segments images from medical scanners and medical 3D models to generate 3D models for diagnostic visualization, measurement, treatment planning, and additive-manufacturing support in pediatric and adult orthopedic, maxillofacial, and cardiovascular workflows.

Evidence takeaway

Evidence from the reviewed source record: K211966 FDA decision material describes the cleared medical-image surgical-planning software, labeled use, and submission-specific verification. It does not establish product-wide sensitivity, specificity, outcomes, or independent clinical validation for this exact configuration.

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
Segment 3DPrint reviews and segments images from medical scanners and medical 3D models to generate 3D models for diagnostic visualization, measurement, treatment planning, and additive-manufacturing support in pediatric and adult orthopedic, maxillofacial, and cardiovascular workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified surgeons, radiologists, and other trained clinical professionals for the labeled procedure.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Hospital, outpatient, operating-room, or surgical-planning workflows within the cleared indication.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Patient-specific image visualization, segmentation, measurement, modeling, and preoperative or intraoperative planning support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported patient CT, MR, X-ray, or other labeled medical images and user-selected planning inputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Three-dimensional models, segmentations, measurements, templates, guides, or navigation views for professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The generated 3D models support diagnostic visualization and planning but require expert review; output accuracy, model editing, manufacturing, and clinical use must be checked locally.
  • 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
K211966
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Radiological images; modality varies or is not specified in FDA list
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Orthopedic, maxillofacial, cardiovascular, and other patient-specific anatomy represented in medical images
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-05-06
  • 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
The exact FDA package describes import of medical images or 3D models from portable or network or vendor systems and export of 3D models for Segment 3DPrint; verify local formats and transfer controls.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is the interface boundary described in the exact FDA package; current local compatibility, routing, identity, and archive behavior still require acceptance testing.

Deployment and data flow
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

The exact public FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

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.

Training and support
Only qualified surgeons, radiologists, and other trained clinical professionals for the labeled procedure should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor K211966 by exact hardware, software, model, and 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. Track these product-specific limits: The generated 3D models support diagnostic visualization and planning but require expert review; output accuracy, model editing, manufacturing, and clinical use must be checked locally.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Monitoring guidance is buyer-facing implementation guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K211966 before acceptance.

exact submission · checked 2026-09-04

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

Source

Deployment boundary

The exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.

exact submission · checked 2026-09-04

FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The exact FDA package describes import of medical images or 3D models from portable or network or vendor systems and export of 3D models for Segment 3DPrint; verify local formats and transfer controls.

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 generated 3D models support diagnostic visualization and planning but require expert review; output accuracy, model editing, manufacturing, and clinical use must be checked locally.

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 reviewed public material; productivity or value claims require local evidence.

Source

Lifecycle monitoring

Monitor K211966 by exact hardware, software, model, and 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. Track these product-specific limits: The generated 3D models support diagnostic visualization and planning but require expert review; output accuracy, model editing, manufacturing, and clinical use must be checked locally.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. medical-image surgical-planning software limits remain submission-specific.

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
K211966 FDA decision material describes the cleared medical-image surgical-planning software, labeled use, and submission-specific verification. It does not establish product-wide sensitivity, specificity, outcomes, or independent clinical validation for this exact configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Sensitivity is not promoted as a product-wide endpoint for this device or software function. Compare only an exact endpoint, threshold, population, version, and source if later verified.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Specificity is not promoted as a product-wide endpoint for this device or software function. Compare only an exact endpoint, threshold, population, version, and source if later verified.

Maximum final 3D model error upper bound

1 mm

  • EndpointMaximum final 3D model error reported in the FDA summary
  • PopulationFDA verification data for the exact Segment 3DPrint configuration
  • Tested versionSegment 3DPrint configuration described in K211966
Source

K211966 FDA evidence package for Segment 3DPrint

  • DesignFDA 510(k) decision evidence including image import, segmentation, model generation, and final-model verification.
  • PopulationOrthopedic, maxillofacial, cardiovascular, and other patient-specific anatomy represented in medical images
  • Scopeexact submission
  • Tested versionSegment 3DPrint configuration described in K211966
  • IndependenceSponsor or vendor study

K211966

Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and 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. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, 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, 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

This is not a product-specific reimbursement determination. Build a local total-cost and value model and verify payer, site-of-service, coding, and coverage assumptions independently.

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 K211966 by exact native 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
2026-09-20Last searched
27Fields reviewed
12Source 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 summary, 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 K211966: Segment 3DPrint

    U.S. Food and Drug Administration - Published 2022-05-06 - 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. K211966 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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