Astrasono A3Pro Bladder Scanner

GUDID 16978669290005

The Astrasono A3Pro Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a handheld battery-operated device. The device projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. It is intended to be used only by qualified medical professionals.

Astrasono technology co.,ltd.

Bladder volume ultrasound imaging system

• Primary Device ID: 16978669290005
• NIH Device Record Key: 904887d2-1ca9-4f3b-8da2-83fe7cf626e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Astrasono A3Pro Bladder Scanner
• Version Model Number: A3Pro
• Company DUNS: 449989331
• Company Name: Astrasono technology co.,ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16978669290005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250331

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-28
• Device Publish Date: 2025-11-20