# K082456: Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600

- Pathway: 510(k) (Abbreviated)
- Applicant: Verathon Incorporated
- Decided: Dec 1, 2008 after 97 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945773 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071217: Bladderscan Bvi 9400 Ultrasound, Verathon Incorporated (2007) Summary page 1.
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 1.

## Recalls of this device
- Nov 30, 2015 · Class II · Z-1091-2016: 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 cl
- Aug 23, 2010 · Not classified · Z-0003-2011: 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.
- Aug 23, 2010 · Not classified · Z-0004-2011: 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.

## Indications for use
Abdomen, B-Mode, per Indications for Use Ultrasound Form The Verathon Inc. BladderScan® BVI 9600 with AortaScan® Mode is a user selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurement. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K082456
Methodology: https://510kreport.com/methodology