# K061368: Diagnosoft Harp

- Pathway: 510(k) (Traditional)
- Applicant: Diagnosoft, Inc.
- Decided: Jul 28, 2006 after 73 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: 2 generations back to K900889 (1990). 2 ancestors in all.
90 later devices descend from it; 1 cites it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973799: Cardiac Tagging Techniques/Magnetom Vision and Magnetom Impact, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.

## Most influential descendants
- K100352: Diagnosoft Harp Model 2.06 (2010), 89 descendants of its own
- K120135: 2D Cardiac Performance Analysis MR 1.0 (2012), 82 descendants of its own
- K132544: Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena (2013), 78 descendants of its own
- K150122: Tomtec-Arena TTA2 (2015), 56 descendants of its own
- K170823: Vivid E80, Vivid E90, Vivid E95 (2017), 35 descendants of its own

## Indications for use
DIAGNOSOFT HARP is a stand-alone software package which provides the capability to review, analyze, and report on magnetic resonance (MR) images. HARP can import images from an MR system and display them in a viewing area on the computer screen. Images can be organized and displayed by study and series and organized into three-dimensional and temporal (multi-phase) collections. Temporal sequences can be displayed in a cine mode to facilitate visualization. Tagged MR images can be imported, displayed, and analyzed. Available measurements include displacement, twist, and radial, circumferential, and principle strains. Tools are provided for display of regional motion properties of the heart. A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out a complete clinical report of an imaging exam. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians in supporting the determination of a diagnosis.

Source page: https://510kreport.com/device/K061368
Methodology: https://510kreport.com/methodology