# K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Nov 5, 2012 after 175 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K971684 (1997). 31 ancestors in all.
215 later devices descend from it; 16 cite it directly.
21 of 247 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111242: Magnetom Aera and Magnetom Skyra, Siemens Medical Solutions USA, Inc. (2011) Summary page 4.
- K082427: Syngo MR B17, Siemens Medical Solutions USA, Inc. (2008) Summary page 4.
- K091114: TXRX 1.5T CP Head Coil; TXRX 3T CP Head Coil, Quality Electrodynamics (2009) Summary page 4.
- K103274: Sentinelle Endo Coil Array for Pelvic Imaging, Sentinelle Medical, Inc. (2011) Summary page 4.
- (no number) MR-Touch: named in the summary without a submission number
- (no number) 3D ASL: named in the summary without a submission number
- (no number) TxRx 1.5T & 3T 15ch Knee Coils: named in the summary without a submission number
- (no number) Sentinelle 16ch Breast Coil: named in the summary without a submission number

## Most influential descendants
- 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
- K130749: Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular (2013), 54 descendants of its own

## Recalls of this device
- Aug 28, 2025 · Class I · Z-2666-2025: 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-2665-2025: 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
- Mar 9, 2015 · Class II · Z-1308-2015: The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur.

## 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/K121434
Methodology: https://510kreport.com/methodology