# K130885: Magnetom Avanto-Fit, Magnetom Skyra-Fit

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 17, 2013 after 49 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (1 Class I)
- 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.
No later device cites it as a predicate yet.
4 of 33 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.
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio, Siemens Medi Cal Solutions, Inc. (2012) Summary page 3.
- 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.

## Recalls of this device
- 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
- Dec 7, 2015 · Class II · Z-0467-2016: Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench 

## Indications for use
The MAGNETOM systems described above 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 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/K130885
Methodology: https://510kreport.com/methodology