Cleared Traditional

K191944 - MU2net

K191944 is the FDA 510(k) clearance for MU2net by Dosisoft. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K191944 · Dosisoft · Radiology device
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Oct 2019
Decision
94d
Days
Class 2
Risk

K191944 is an FDA 510(k) clearance for the MU2net. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Dosisoft (Cachan, FR). The FDA issued a Cleared decision on October 24, 2019 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Dosisoft devices

Submission Details

510(k) Number K191944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2019
Decision Date October 24, 2019
Days to Decision 94 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
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

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