Cleared Traditional

Rayvolve LN

K243831 · AZmed · Radiology
Mar 2025
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K243831 is an FDA 510(k) clearance for the Rayvolve LN, a Analyzer, Medical Image (Class II — Special Controls, product code MYN), submitted by AZmed (Paris, FR). The FDA issued a Cleared decision on March 26, 2025, 103 days after receiving the submission on December 13, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2070.

Submission Details

510(k) Number K243831 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2024
Decision Date March 26, 2025
Days to Decision 103 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MYN — Analyzer, Medical Image
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2070
Definition For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers