# K151579: MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 29, 2015 after 110 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K971684 (1997). 33 ancestors in all.
85 later devices descend from it; 1 cites it directly.
18 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141977: Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel, Siemens Medical Solutions USA, Inc. (2014) Summary page 7.

## Most influential descendants
- K153343: MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit (2016), 84 descendants of its own
- K170396: MAGNETOM Vida (2017), 30 descendants of its own
- K181433: MAGNETOM Vida (2018), 28 descendants of its own
- K183254: Magnetom Vida (2019), 26 descendants of its own
- K163294: syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology (2017), 23 descendants of its own

## Recalls of this device
- Aug 28, 2025 · Class I · Z-2659-2025: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, l
- Aug 28, 2025 · Class I · Z-2661-2025: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, l

## Indications for use
The MAGNETOM systems are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display 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. The MAGNETOM systems described above 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.

Source page: https://510kreport.com/device/K151579
Methodology: https://510kreport.com/methodology