FDA 510(k)

Astrasono A3Pro Bladder Scanner (A3Pro)

K-Number: K250331 · 2025-09-30

Decision Date2025-09-30

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Astrasono A3Pro Bladder Scanner (A3Pro) is a medical device manufactured by Astrasono Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-30 under approval number K250331. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Astrasono A3Pro Bladder Scanner (A3Pro)?

Astrasono A3Pro Bladder Scanner (A3Pro) is a medical device that received FDA 510(k) clearance on 2025-09-30. It is manufactured by Astrasono Technology Co., Ltd.. The 510(k) number is K250331.

When was Astrasono A3Pro Bladder Scanner (A3Pro) approved by the FDA?

Astrasono A3Pro Bladder Scanner (A3Pro) received FDA 510(k) clearance on 2025-09-30, under approval number K250331.

What company makes Astrasono A3Pro Bladder Scanner (A3Pro)?

Astrasono A3Pro Bladder Scanner (A3Pro) is manufactured by Astrasono Technology Co., Ltd..

What is the FDA product code for Astrasono A3Pro Bladder Scanner (A3Pro)?

The FDA product code for Astrasono A3Pro Bladder Scanner (A3Pro) is IYO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.