Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600

510(k) K082456

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Abbreviated	NumberK082456	Date1 Dec 2008Cleared	StatusActive

3 recalls · FDA

- Terminated Z-1091-2016 FDA Class II initiated 30 Nov 2015
The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs).
- Terminated Z-0003-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
The BladderScan BVI 9600 with AortaScan devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.
- Terminated Z-0004-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010
The AortaScan AMI 9700 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.

1 jurisdiction

United States — FDA 510(k) Active

510(k)