Bladder Scanner M4
by Suzhou PeakSonic Medical Technology Co., LTD. 2 variants
Bladder Scanner M4 is a Class II device made by Suzhou PeakSonic Medical Technology Co., LTD., cleared under FDA 510(k) K201316 on 26 Feb 2021 and listed in FDA GUDID since 13 Apr 2022 (UDI-DI 06975124100537), active as of 22 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 | Number06975124100537 | Date13 Apr 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201316 | Date26 Feb 2021 | StatusActive |
Official records
- AccessGUDID record 06975124100537
- FDA 510(k) database K201316
Across registries
- FDA 510(k) K201316 decided 26 Feb 2021 Active
- FDA GUDID UDI-DI 06975124100537 listed 13 Apr 2022 Listed
Timeline
- Cleared FDA 510(k) K201316
- Listed FDA GUDID 06975124100537
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bladder Scanner
- Generic name
- Bladder volume ultrasound imaging system
- Model / reference
- M4
- Primary DI / UDI-DI
- 06975124100537
- 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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