# K973799: Cardiac Tagging Techniques/Magnetom Vision and Magnetom Impact

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 2, 1998 after 88 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: 1 generation back to K900889 (1990). 1 ancestor in all.
95 later devices descend from it; 3 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900889: Magnetic Resonance Diagnostic Device Accessories, Siemens Medical Solutions USA, Inc. (1990) Summary page 2.

## Most influential descendants
- K061368: Diagnosoft Harp (2006), 90 descendants of its own
- 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

## Indications for use
Siemens developed Cardiac Tagging pulse sequences for the Magnetom Vision and Impact Systems to allow for the non-invasive evaluation of cardiac wall motion and blood flow. Absence of tag deformation throughout the cardiac cycle is an indicator of dysfunctional myocardium which accompanies a variety of disease states. In addition, Cardiac Tagging may assist in differentiating between fixed thrombus and slowly flowing blood. Cardiac Tagging is intended as an add-on to routine MR imaging examinations of the heart and great vessels. Tagging may provide additional diagnostic information, which in the hands of a qualified physician, can be useful in the diagnosis of disease.

Source page: https://510kreport.com/device/K973799
Methodology: https://510kreport.com/methodology