# K121160: Magnetom Spectra

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 16, 2012 after 91 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 3 (1 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). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 14 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.
- K072237: Magnetom Verio, Siemens Medical Solutions USA, Inc. (2007) Summary page 2.
- K082427: Syngo MR B17, Siemens Medical Solutions USA, Inc. (2008) Summary page 2.
- (no number) Hardware and Software Updates to MAGNETOM Aera (1.5T) and Skyra (3T): named in the summary without a submission number

## Most influential descendants
- K153447: MAGNETOM Spectra (2016), 0 descendants of its own

## Recalls of this device
- Aug 28, 2025 · Class I · Z-2663-2025: 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
- Jul 9, 2019 · Class II · Z-2344-2019: Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.
- Sep 12, 2012 · Class II · Z-2464-2012: When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with resp

## Indications for use
The MAGNETOM Spectra is 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 Spectra may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom display and MR-safe biopsy needles.

Source page: https://510kreport.com/device/K121160
Methodology: https://510kreport.com/methodology