Cleared Traditional

MAMMOMAT B.brilliant

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

About This 510(k) Submission

K233539 is an FDA 510(k) clearance for the MAMMOMAT B.brilliant, a Full Field Digital, System, X-ray, Mammographic (Class II — Special Controls, product code MUE), submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on March 27, 2024, 145 days after receiving the submission on November 3, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number K233539 FDA.gov
FDA Decision Cleared 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

Device Classification

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