brAIn™ Shoulder Positioning

FDA 510(k) K243292 · Avatar Medical

Substantially Equivalent

510(k) numberK243292

Submission

Device name
brAIn™ Shoulder Positioning
Applicant
Avatar Medical
Paris, FR
Received
October 18, 2024
Decision date
March 20, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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More from Avara Software

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K253950Avatar Medical VisionLLZ · Traditional 03/30/2026SE
K252665brAIn™ Shoulder PositioningQIH · Traditional 10/20/2025SE
K222035Avatar Medical Software V1LLZ · Traditional 05/24/2023SE

Questions and answers

When was brAIn™ Shoulder Positioning cleared by the FDA?

brAIn™ Shoulder Positioning (K243292) received a 510(k) decision of Substantially Equivalent on March 20, 2025, 153 days after the submission was received.

What is the product code of K243292?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.