PMA · Radiology

Senographe Pristina 3D

by GE Healthcare

Senographe Pristina 3D is an AI-enabled medical device from GE Healthcare that the U.S. FDA approved through PMA P130020/S005 on November 21, 2025. Its lead review panel is Radiology and its primary product code is OTE.

See also FDA-cleared AI radiology devices in 2025, all FDA AI clearances in 2025, top radiology AI devices.

Key facts

Submission numberP130020/S005
PathwayPMA
Date of final decision
Company (FDA list)GE Healthcare
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. Senographe Pristina 3D went through this pathway (P130020/S005).

Product code OTE covers 2 devices on the FDA AI list. By decision date, this device is #2 of 2 under that code. GE Healthcare has 8 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.

Similar devices (product code OTE)

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