# K163211: MAGNETOM Sempra with syngo MR E11S

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 27, 2017 after 72 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K971684 (1997). 50 ancestors in all.
7 later devices descend from it; 1 cites it directly.
3 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152283: MAGNETOM Amira, Siemens Medical Solutions USA, Inc. (2015) Summary page 5.

## Most influential descendants
- K183221: MAGNETOM Amira, MAGNETOM Sempra (2019), 6 descendants of its own
- 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

## Indications for use
The MAGNETOM Sempra 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 Sempra 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/K163211
Methodology: https://510kreport.com/methodology