Caresono HD3
by Caresono Technology Co., Ltd.
Caresono HD3 is a Class II device made by Caresono Technology Co., Ltd., cleared under FDA 510(k) K131227 on 12 Jul 2013 and listed in FDA GUDID since 4 Feb 2025 (UDI-DI 16971003430020), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number16971003430020 | Date4 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131227 | Date12 Jul 2013 | StatusActive |
Official records
- AccessGUDID record 16971003430020
- FDA 510(k) database K131227
Across registries
- FDA 510(k) K131227 decided 12 Jul 2013 Active
- FDA GUDID UDI-DI 16971003430020 listed 4 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K131227
- Listed FDA GUDID 16971003430020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Caresono
- Generic name
- Bladder volume ultrasound imaging system
- Model / reference
- HD3
- Primary DI / UDI-DI
- 16971003430020
- 510(k) Number
- FDA product code
- ITX, IYO
- GMDN term
- Bladder volume ultrasound imaging system
- Device class
- Class II
- Regulation number
- 892.1570, 892.1560
- GUDID distribution status
- In Commercial Distribution
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