# K031927: GE Delta Software Option for Mri

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jul 2, 2003 after 9 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940172 (1994). 5 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994282: Mri- Flow Analytical Software Package, Medis Medical Imaging Systems BV (2000) Summary page 2.
- K994283: Mri- Magnetic Resonance Analytical Software System, Medis Medical Imaging Systems BV (2000) Summary page 2.

## Most influential descendants
- K121762: Cardiac VX (2013), 21 descendants of its own
- K140587: MR-CT Vva (2015), 19 descendants of its own
- K191125: ADAS 3D (2020), 5 descendants of its own
- K162513: Arterys Software v2.0 (2016), 5 descendants of its own
- K210850: ADAS 3D (2021), 4 descendants of its own

## Indications for use
The GE Delta Software Option for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. Delta can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization. A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians. When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.

Source page: https://510kreport.com/device/K031927
Methodology: https://510kreport.com/methodology