# K183221: MAGNETOM Amira, MAGNETOM Sempra

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 14, 2019 after 86 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 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). 55 ancestors in all.
6 later devices descend from it; 2 cite it directly.
5 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173600: MAGNETOM Amira, Siemens Medical Solutions USA, Inc. (2017) Summary page 5.
- K163211: MAGNETOM Sempra with syngo MR E11S, Siemens Medical Solutions USA, Inc. (2017) Summary page 5.
- K181322: MAGNETOM Sola, Siemens Medical Solutions USA, Inc. (2018) Summary page 5.

## Most influential descendants
- K210611: MAGNETOM Free.Max (2021), 4 descendants of its own
- K220575: MAGNETOM Free.Max, MAGNETOM Free.Star (2022), 3 descendants of its own
- K231617: MAGNETOM Free.Max; MAGNETOM Free.Star (2023), 2 descendants of its own
- K251822: MAGNETOM Free.Max; MAGNETOM Free.Star (2025), 1 descendant of its own
- K260758: MAGNETOM Free.Max; MAGNETOM Free.Star (2026), 0 descendants of its own

## Recalls of this device
- Sep 1, 2023 · Class II · Z-2648-2023: In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. Thes

## Indications for use
Your MAGNETOM MR system 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. Your MAGNETOM MR system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

Source page: https://510kreport.com/device/K183221
Methodology: https://510kreport.com/methodology