Cleared Traditional

K220164 - Rayvolve
(FDA 510(k) Clearance)

K220164 · Azmed Sas · Radiology
Jun 2022
Decision
133d
Days
Class 2
Risk

K220164 is an FDA 510(k) clearance for the Rayvolve, a Radiological Computer Assisted Detection/diagnosis Software For Fracture (Class II — Special Controls, product code QBS), submitted by Azmed Sas (Laval, FR). The FDA issued a Cleared decision on June 2, 2022, 133 days after receiving the submission on January 20, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2090.

Submission Details

510(k) Number K220164 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2022
Decision Date June 02, 2022
Days to Decision 133 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.