UNiD Spine Analyzer (SW3002)— 510(k) K261289

Name: FDA 510(k) clearance K261289
Creator: U.S. Food and Drug Administration
Published: 2026-05-15

Substantially Equivalent

Medicrea International S.A.S. (Medtronic)

FDA 510(k) clearance K261289 for UNiD Spine Analyzer (SW3002), Substantially Equivalent on 2026-05-15. Applicant: Medicrea International S.A.S. (Medtronic). Device class: 2.

Summary

The UNiD Spine Analyzer (SW3002) comes from Medicrea International, which the record lists with "Medtronic" in parentheses. It's filed under QIH, automated radiological image processing software.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and the submission was a Special 510(k).

Medicrea filed from Rillieux-La-Pape, France. Review took 25 calendar days (April 20 to May 15, 2026).

Clearance details

Applicant: Medicrea International S.A.S. (Medtronic)
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-04-20
Decision date: 2026-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Rillieux-La-Pape, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.