BladderScan® BVI 6000 Series
BladderScan® BVI 6000 Series (0270-0793) is a Class II device made by Verathon Inc, cleared under FDA 510(k) K022153 on 15 Aug 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10879123003123), active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10879123003123 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK022153 | Date15 Aug 2002 | StatusActive |
Official records
- AccessGUDID record 10879123003123
- FDA 510(k) database K022153
Across registries
- FDA 510(k) K022153 decided 15 Aug 2002 Active
- FDA GUDID UDI-DI 10879123003123 listed 24 Sep 2016 Listed
Recalls
-
- Terminated Z-0143-2011
Incorrect programming causes QuickPrint to fail to recognize the communication Cradles. As a result, ScanPoint Communications Cradles could not communicate with ScanPoint Online Tool while using the QuickPrint interface. This will affect the transfer of exams and device calibration through QuickPrint interface.
Timeline
- Cleared FDA 510(k) K022153
- Recall initiated FDA recalls Z-0143-2011
- Listed FDA GUDID 10879123003123
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BladderScan®
- Generic name
- Bladder volume ultrasound imaging system
- Model / Ref / Catalog
- BVI 6000 Series, 0270-0793
- Primary DI / UDI-DI
- 10879123003123
- 510(k) Number
- FDA product code
- IYO
- GMDN term
- Bladder volume ultrasound imaging system
- Device class
- Class II
- Regulation number
- 892.1560
- GUDID distribution status
- In Commercial Distribution
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