Data / Medical devices / China / Caresono Technology Co.,ltd.
Caresono Technology Co.,ltd.: FDA-registered device maker in Dandong Liaoning, China, 2 510(k) clearances
Caresono Technology Co.,ltd. is registered with the FDA (registration 3010457937) in Dandong Liaoning, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 8, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010457937
- Address
- 4th Floor of Building 2, No. 2 Baoquan Road, Jinquan Industrial Zone Lingang Industrial Park, Dandong City, Liaoning Province, 118009, China, Dandong Liaoning, China, 118009
- Owner or operator
- Caresono Technology Co.,Ltd. (10044881)
- Roles
- Manufacturer
- First device listed
- August 13, 2013
- Registered through
- 2026
- Brand names listed
- Bladder Scanner PadScan HD2, BladderVU, PadScan HD 3, PadScan HD 5
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 |
|---|---|---|---|---|---|---|
| April 8, 2016 | K153581 | Bladder Scanner | IYO | Substantially Equivalent | Caresono Technology Co., Ltd. | accessdata.fda.gov |
| July 12, 2013 | K131227 | PADSCAN HD SERIES BLADDER SCANNER | IYO | Substantially Equivalent | Carenoso Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
Updated April 8, 2016. 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.