# K111242: Magnetom Aera and Magnetom Skyra

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 23, 2011 after 204 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K971684 (1997). 22 ancestors in all.
220 later devices descend from it; 2 cite it directly.
21 of 243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101347: Magnetom Aera; Magnetom Skyra, Siemens Medical Solutions USA, Inc. (2010) Summary page 2.
- K082427: Syngo MR B17, Siemens Medical Solutions USA, Inc. (2008) Summary page 2.
- K072237: Magnetom Verio, Siemens Medical Solutions USA, Inc. (2007) Summary page 2.
- K041112: Magnetom Espree System, Siemens Medical Solutions USA, Inc. (2004) Summary page 2.
- K103275: Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR Systems, Siemens Medical Solutions USA, Inc. (2011) Summary page 2.
- K100113: Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System, Model 4000451-51, Sentinelle Medical, Inc. (2010) Summary page 2.

## Most influential descendants
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio (2012), 215 descendants of its own
- K141977: Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel (2014), 115 descendants of its own
- K151579: MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit (2015), 85 descendants of its own
- K153343: MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit (2016), 84 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own

## Recalls of this device
- Jul 9, 2019 · Class II · Z-2342-2019: Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
- Jul 9, 2019 · Class II · Z-2343-2019: Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
- Apr 24, 2014 · Class II · Z-1663-2014: Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.

## Indications for use
The MAGNETOM systems described above 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/K111242
Methodology: https://510kreport.com/methodology