PMA · Radiology

MAMMOMAT B.brilliant with Tomosynthesis Option

by SIEMENS MEDICAL SOLUTIONS USA, INC.

MAMMOMAT B.brilliant with Tomosynthesis Option is an AI-enabled medical device from SIEMENS MEDICAL SOLUTIONS USA, INC. that the U.S. FDA approved through PMA P140011/S008 on September 23, 2024. Its lead review panel is Radiology and its primary product code is OTE.

See also FDA-cleared AI radiology devices in 2024, all FDA AI clearances in 2024, top radiology AI devices.

Key facts

Submission numberP140011/S008
PathwayPMA
Date of final decision
Company (FDA list)SIEMENS MEDICAL SOLUTIONS USA, INC.
Lead review panelRadiology
Primary product codeOTE

Source: FDA AI-Enabled Medical Devices list. No matching openFDA record was found for this submission yet.

What this means

Premarket Approval (PMA) is FDA's most stringent pathway, used for Class III devices. It requires valid scientific evidence of safety and effectiveness. MAMMOMAT B.brilliant with Tomosynthesis Option went through this pathway (P140011/S008).

Product code OTE covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. SIEMENS MEDICAL SOLUTIONS USA, INC. has 67 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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