# K191050: MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 12, 2019 after 84 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: 13 generations back to K971684 (1997). 35 ancestors in all.
No later device cites it as a predicate yet.
5 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio, Siemens Medi Cal Solutions, Inc. (2012) Summary page 5.
- K153343: MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit, Siemens Medi Cal Solutions, Inc. (2016) Summary page 7.

## Indications for use
Your MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles. Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow, when used with a gadolinium-based contrast agent (GBCA) approved for cardiac MRI (CMRI) is indicated for the acquisition and display of images of myocardial perfusion (stress, rest) and late gadolinium enhancement (LGE) during post-contrast CMRI examination in patients with known or suspected coronary artery disease (CAD).

Source page: https://510kreport.com/device/K191050
Methodology: https://510kreport.com/methodology