Radiology AI Directory

FDA-cleared profile

UNiD Spine Analyzer

Medicrea International

Assists healthcare professionals in viewing and measuring images and planning orthopedic surgeries, including generic and spine-related measurements, surgical planning, and implant-placement measurements.

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.

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
Assists healthcare professionals in viewing and measuring images and planning orthopedic surgeries, including generic and spine-related measurements, surgical planning, and implant-placement measurements.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Healthcare professionals, including surgeons and service providers.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Orthopedic surgical-planning workflow; the FDA packet does not specify a facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Web-based image measurement and preoperative planning with osteotomy and implant templating.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Locally supplied images in JPEG, PNG, or GIF; the FDA packet does not specify an acquisition modality or PACS input.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Generic and spine measurements overlaid on images, osteotomy plans, implant templates for screws/cages/rods, and anatomical-component measurements for implant placement.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Clinical judgment and experience are required; surgeons must validate planning before any implant manufacturing. The packet provides non-clinical verification/validation evidence and does not establish a clinical outcome endpoint.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K180091
  • 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 2026-09-09
Anatomy
Spine and anatomical components used for implant placement.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2018-02-08
  • 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
Web-based software running on PC-compatible Windows or Mac with a server; the subject-device comparison lists local image input and no PACS connectivity.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for UNiD Spine Analyzer; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
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
Non-clinical verification/validation compared measurements with the predicate: distance mean error 0.23 mm (SD 0.42), angle mean error 0.2 degrees (SD 0.4), wedge-tool mean error 0.25 degrees (SD 0.44), and cage-tool mean error 0.4 degrees (SD 0.5). These are measurement-error/agreement endpoints, not diagnostic sensitivity, specificity, or AUC.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

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

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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

No public price or quote for the exact K180091 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-09

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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 exact-identifier FDA recall query returned no native recall record for K180091. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

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.

Exact FDA record reviewedStatus
2026-09-09Last searched
18Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 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, acr ai central product, 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 K180091: UNiD Spine Analyzer

    U.S. Food and Drug Administration - Published 2018-02-08 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. UNiD Spine Analyzer model card (K180091)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: anatomy

  4. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K180091

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

    Scope: postmarketSafety

Research history

  1. K180091 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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