Cleared Traditional

UNiD? Spine Analyzer

K251629 · Medicrea International S.A.S. (Medtronic) · Radiology
Aug 2025
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K251629 is an FDA 510(k) clearance for the UNiD? Spine Analyzer, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Medicrea International S.A.S. (Medtronic) (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on August 7, 2025, 71 days after receiving the submission on May 28, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K251629 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2025
Decision Date August 07, 2025
Days to Decision 71 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QIH — Automated Radiological Image Processing Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.