# K101707: Fulaccess Model 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Fulcrum Medical, Inc.
- Decided: Oct 29, 2010 after 134 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K954874 (1996). 57 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071964: Mim 4.1 (Seastar), Mimvista Corp. (2007) Summary page 1.
- K081076: Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response, Velocity Medical Solutions, LLC (2008) Summary page 1.

## Most influential descendants
- K182855: ProKnow DS (2019), 2 descendants of its own
- K251363: ProKnow DS (2025), 0 descendants of its own
- K193498: Infinitt RT PACS (2020), 0 descendants of its own

## Indications for use
fulAccess is a standalone software product that provides basic image processing and communication functionality for use in radiology, oncology, and other clinical specialties. With fulAccess the user can review images from different modalities including CT, MR, and PET, perform basic functions including zoom, pan, measure, sample pixel intensity, and make annotations. Users may also create and save a set of files that include a copy of the data being viewed, any annotations, and an instance of the viewer executable. These files can be stored locally or on portable media (e.g. CD and DVD). fulAccess is a Windows application and will be used on recommended hardware that is provided by the company or the end user. fulAccess is a stand-alone software package that assists users in the display, analysis, comparison and communication of medical imaging data from various sources. It allows the display, analysis, annotation, and communication of medical images. The intended users of fulAccess are trained medical professionals including physicians, nurses, physicists and other medical technologists. fulAccess is not intended for use in mammography.

Source page: https://510kreport.com/device/K101707
Methodology: https://510kreport.com/methodology