Caresono HD2
by Caresono Technology Co., Ltd.
Caresono HD2 is a Class II device made by Caresono Technology Co., Ltd., cleared under FDA 510(k) K153581 on 8 Apr 2016 and listed in FDA GUDID since 4 Feb 2025 (UDI-DI 16971003430037), 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 | Number16971003430037 | Date4 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153581 | Date8 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 16971003430037
- FDA 510(k) database K153581
Across registries
- FDA 510(k) K153581 decided 8 Apr 2016 Active
- FDA GUDID UDI-DI 16971003430037 listed 4 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K153581
- Listed FDA GUDID 16971003430037
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- Withdrawn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
- HD2
- Primary DI / UDI-DI
- 16971003430037
- 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
Similar devices
Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).
- X12C4 Transducer 9026 by Bk Medical ApS
- Convex probe C3S-E by CHISON Medical Technologies Co., Ltd.
- MYLAB40 by Esaote Europe B.V.
- iLOOK P35004-04 by Fujifilm Sonosite, Inc.
- UNBRANDED 20-PC548 by Advance Medical Designs, Inc.
- L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC by Parexel Intl. Corp.
- 9EC4 Transducer 10787117 by SIEMENS MEDICAL SOLUTIONS USA, INC.
- Doppler-Box X DBX1 7780 by Compumedics Germany Gmgh
- L8-18i-RS by GE HEALTHCARE JAPAN CORPORATION
- USHIFU STEPPER by Ushifu Development Company, LLC