BladderScan® Prime
BladderScan Prime (0620-0739) is an ultrasound system quality assurance device (FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Verathon Inc, cleared under FDA 510(k) K153101 on 19 Nov 2015 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00879123005496), active as of 8 Nov 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 | Number00879123005496 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153101 | Date19 Nov 2015 | StatusActive |
Official records
- AccessGUDID record 00879123005496
- FDA 510(k) database K153101
Across registries
- FDA 510(k) K153101 decided 19 Nov 2015 Active
- FDA GUDID UDI-DI 00879123005496 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K153101
- Listed FDA GUDID 00879123005496
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BladderScan®
- Generic name
- Ultrasound system quality assurance device
- Model / Ref / Catalog
- Prime, 0620-0739
- Primary DI / UDI-DI
- 00879123005496
- 510(k) Number
- FDA product code
- IYO
- GMDN term
- Ultrasound system quality assurance device
- Device class
- Class II
- Regulation number
- 892.1560
- GUDID distribution status
- In Commercial Distribution
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