Cleared Traditional

TechCare Trauma

K242171 · Milvue · Radiology
Jan 2025
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K242171 is an FDA 510(k) clearance for the TechCare Trauma, a Radiological Computer Assisted Detection/diagnosis Software For Fracture (Class II — Special Controls, product code QBS), submitted by Milvue (Paris, FR). The FDA issued a Cleared decision on January 17, 2025, 177 days after receiving the submission on July 24, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2090.

Submission Details

510(k) Number K242171 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2024
Decision Date January 17, 2025
Days to Decision 177 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QBS — Radiological Computer Assisted Detection/diagnosis Software For Fracture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2090
Definition A Radiological Computer Assisted Detection And Diagnostic Software For Suspected Fracture Is An Image Processing Device Intended To Aid In The Detection, Localization, And/or Characterization Of Fracture On Acquired Medical Images (e.g. Radiography, Mr, Ct). The Device Detects, Identifies And/or Characterizes Fracture Based On Features Or Information Extracted From Images, And May Provide Information About The Presence, Location, And/or Characteristics Of The Fracture To The User. Primary Diagnostic And Patient Management Decisions Are Made By The Clinical User.