Data / Medical devices / China / Astrasono Technology Co., Ltd.
Astrasono Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Astrasono Technology Co., Ltd. is registered with the FDA (registration 3042254626) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042254626
- Address
- 805B, Nangang Business Building, 1428 Qianhai Rd, Xiangnan Community, Nanshan Subdistrict, Nanshan, Shenzhen Guangdong, China, 518052
- Owner or operator
- Astrasono Technology Co., Ltd. (10094127)
- Roles
- Manufacturer
- First device listed
- November 16, 2025
- Registered through
- 2026
- Brand names listed
- Astrasono A3Essential Bladder Scanner (A3Essential), Astrasono A3Pro Bladder Scanner (A3Pro), Astrasono A3Pro Lite Bladder Scanner (A3Pro Lite), Astrasono A5Pro Bladder Scanner (A5Pro)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 30, 2025 | K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | IYO | Substantially Equivalent | Astrasono Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated September 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.