# K123510: Magnetom Skyra

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 17, 2013 after 185 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: 10 generations back to K971684 (1997). 32 ancestors in all.
16 later devices descend from it; 3 cite it directly.
4 of 49 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 3.

## Most influential descendants
- K132119: Magnetom Prisma, Magnetom Prisma Fit (2013), 12 descendants of its own
- K181370: uMR 780 (2018), 11 descendants of its own
- K181371: uMR 790 (2018), 11 descendants of its own
- K191157: uMR 780, uMR 790 (2019), 10 descendants of its own
- K193200: uMR Omega (2020), 8 descendants of its own

## Indications for use
The MAGNETOM Skyra 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 inf6rmation that may assist in diagnosis. The MAGNETOM Skyra may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR-safe biopsy needles.

Source page: https://510kreport.com/device/K123510
Methodology: https://510kreport.com/methodology