# K081076: Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response

- Pathway: 510(k) (Special)
- Applicant: Velocity Medical Solutions, LLC
- Decided: Jun 20, 2008 after 65 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K954874 (1996). 56 ancestors in all.
63 later devices descend from it; 6 cite it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070248: Velocityais, Velocity Medical Solutions, LLC (2007) Summary page 1.
- K010336: Advantage Windows CT/Pet Fusion, Ge Medical Systems, Inc. (2001)
- K041521: Volume Viewer Plus, General Electric Medical Systems (2004) Summary page 1.
- K071964: Mim 4.1 (Seastar), Mimvista Corp. (2007) Summary page 1.

## Most influential descendants
- K130393: Mirada RTX (2013), 36 descendants of its own
- K181572: Workflow Box (2018), 25 descendants of its own
- K153014: Mobius3D (2016), 13 descendants of its own
- K173636: Velocity (2018), 8 descendants of its own
- K132045: Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options (2013), 8 descendants of its own

## Recalls of this device
- Jul 25, 2013 · Class II · Z-1275-2014: An anomaly was detected such that, under certain conditions, a summed dose created by Velocity replaces the calculated dose from an approved plan in Eclipse when importing the dose from Velocity.

## Indications for use
VelocityAIS (VelocityAI) is a stand-alone software product that provides the physician a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. VelocityAIS (VelocityAl) is not intended for mammography diagnosis.

Source page: https://510kreport.com/device/K081076
Methodology: https://510kreport.com/methodology