# K082427: Syngo MR B17

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 7, 2008 after 77 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: 6 generations back to K971684 (1997). 10 ancestors in all.
229 later devices descend from it; 9 cite it directly.
22 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072237: Magnetom Verio, Siemens Medical Solutions USA, Inc. (2007) Summary page 3.
- K062454: Magnetom Systems - I-Class and T-Class Releases, Siemens Medi Cal Solutions, Inc. (2006) Summary page 3.

## Most influential descendants
- K101347: Magnetom Aera; Magnetom Skyra (2010), 224 descendants of its own
- K111242: Magnetom Aera and Magnetom Skyra (2011), 220 descendants of its own
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio (2012), 215 descendants of its own
- 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

## 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/K082427
Methodology: https://510kreport.com/methodology