Cleared Traditional

Astrasono A3Pro Bladder Scanner (A3Pro)

K250331 · Astrasono Technology Co., Ltd. · Radiology

Sep 2025

Decision

237d

Days

Class 2

Risk

About This 510(k) Submission

K250331 is an FDA 510(k) clearance for the Astrasono A3Pro Bladder Scanner (A3Pro), a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Astrasono Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 30, 2025, 237 days after receiving the submission on February 5, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K250331 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2025
Decision Date	September 30, 2025
Days to Decision	237 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF