EFAI ChestSuite XR Pneumothorax Assessment System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K221552 ↗

FDA Product Code

QFM

Device Class

Class II

Regulation

21 CFR Part 892.2080

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ever Fortune.Ai, Co., Ltd. →