Medicrea International S.A.S. (Medtronic) radiology AI products

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Which exact product, version and licensed modules are in the current offer?
Do related FDA submissions document the same scope, or different functions and versions?
Which costs, support obligations and local acceptance tests remain unresolved?

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Radiology AI pricing and total cost of ownership

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FDA-cleared K261289

UNiD™ Spine Analyzer (SW3002)

Medicrea International S.A.S. (Medtronic)

Authorized purpose: UNiD Spine Analyzer SW3002 v5.1.0 enables healthcare professionals to view and measure images and plan orthopedic spine surgeries, including preoperative and postoperative measurements and patient-specific rod or implant planning.

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Spine
Decision: 2026-05-15

MSK and bone Quantification and segmentation

FDA-cleared K251629

UNiD™ Spine Analyzer

Medicrea International S.A.S. (Medtronic)

Authorized purpose: UNiD Spine Analyzer assists healthcare professionals in viewing and measuring images and planning orthopedic spine surgery, including preoperative and postoperative measurements, surgical-strategy simulation, and patient-specific or standard implant planning; clinical judgment and surgeon validation remain required.

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Spine
Decision: 2025-08-07

MSK and bone Quantification and segmentation