Cleared Traditional

K261378 - Rayvolve AZchest

K261378 is an FDA 510(k) clearance for Rayvolve AZchest, manufactured by AZmed. The device is a Class 2 Radiology device with product code QBS cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K261378 · AZmed · Radiology device
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Aug 2026
Decision
123d
Days
Class 2
Risk

K261378 is an FDA 510(k) clearance for the Rayvolve AZchest. Classified as Radiological Computer Assisted Detection/diagnosis Software For Fracture (product code QBS), Class II - Special Controls.

Submitted by AZmed (Paris, FR). The FDA issued a Cleared decision on August 28, 2026 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2090 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all AZmed devices

FDA 510(k) Submission Details - K261378

510(k) Number K261378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2026
Decision Date August 28, 2026
Days to Decision 123 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 107d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QBS Device Classification - Class 2, Special Controls

Product Code QBS Radiological Computer Assisted Detection/diagnosis Software For Fracture
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QBS Radiological Computer Assisted Detection/diagnosis Software For Fracture

All 10
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