BladderScan® BVI 6000 Series
BladderScan BVI 6000 Series (0570-0155) is a noninvasive device battery charger (FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) 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 00879123001634), active as of 8 Nov 2026.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00879123001634 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK022153 | Date15 Aug 2002 | StatusActive |
Official records
- AccessGUDID record 00879123001634
- FDA 510(k) database K022153
Across registries
- FDA 510(k) K022153 decided 15 Aug 2002 Active
- FDA GUDID UDI-DI 00879123001634 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 00879123001634
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BladderScan®
- Generic name
- Noninvasive device battery charger
- Model / Ref / Catalog
- BVI 6000 Series, 0570-0155
- Primary DI / UDI-DI
- 00879123001634
- 510(k) Number
- FDA product code
- IYO
- GMDN term
- Noninvasive device battery charger
- Device class
- Class II
- Regulation number
- 892.1560
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Noninvasive device battery charger.