Cleared Traditional

K233539 - MAMMOMAT B.brilliant

K233539 is an FDA 510(k) clearance for MAMMOMAT B.brilliant, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code MUE cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K233539 · Siemens Medical Solutions USA, Inc. · Radiology device
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Mar 2024
Decision
145d
Days
Class 2
Risk

K233539 is an FDA 510(k) clearance for the MAMMOMAT B.brilliant. Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on March 27, 2024 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1715 - 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K233539

510(k) Number K233539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2023
Decision Date March 27, 2024
Days to Decision 145 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
38d slower than avg
Panel avg: 107d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUE Device Classification - Class 2, Special Controls

Product Code MUE Full Field Digital, System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1715
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.

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