# K173592: MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 13, 2018 after 84 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: 14 generations back to K971684 (1997). 37 ancestors in all.
3 later devices descend from it; 2 cite it directly.
7 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163312: MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software, Siemens Medical Solutions USA, Inc. (2017) Summary page 6.
- K153343: MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit, Siemens Medi Cal Solutions, Inc. (2016) Summary page 5.
- K162102: MAGNETOM Avantofit, MAGNETOM Skyrafit, Siemens Medi Cal Solutions, Inc. (2016) Summary page 5.

## Most influential descendants
- K182299: MAGNETOM Aera (2018), 1 descendant of its own
- K190757: MAGNETOM Avanto Fit (2019), 0 descendants of its own
- K190138: MAGNETOM Aera (2019), 0 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 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. The MAGNETOM systems 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/K173592
Methodology: https://510kreport.com/methodology