510(k) K250331
K250331 is an FDA 510(k) premarket notification submitted by Astrasono Technology Co., Ltd. for the device "Astrasono A3Pro Bladder Scanner (A3Pro)". The FDA issued a decision of Substantially Equivalent on September 30, 2025. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 2025
- Date Received
- February 5, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type