Cleared Traditional

Rayvolve PTX-PE

K243808 · AZmed · Radiology
Mar 2025
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K243808 is an FDA 510(k) clearance for the Rayvolve PTX-PE, a Radiological Computer-assisted Prioritization Software For Lesions (Class II — Special Controls, product code QFM), submitted by AZmed (Paris, FR). The FDA issued a Cleared decision on March 21, 2025, 100 days after receiving the submission on December 11, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2080.

Submission Details

510(k) Number K243808 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2024
Decision Date March 21, 2025
Days to Decision 100 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QFM — Radiological Computer-assisted Prioritization Software For Lesions
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2080
Definition Radiological Computer-assisted Prioritization Software For Lesions Is An Image Processing Device Intended To Aid In Prioritization And Triage Of Time Sensitive Patient Detection And Diagnosis Based On The Analysis Of Medical Images Acquired From Radiological Signal Acquisition Systems. The Device Identifies Or Prioritizes Time Sensitive Imaging For Review By Prespecified Clinical Users Based On Software-based Image Analysis But Does Not Provide Information From The Image Analysis Other Than Triage And Notification.