# K123938: Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR B19 for Magnetom Symphony a Tim System, Syn

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 12, 2013 after 54 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: 10 generations back to K971684 (1997). 32 ancestors in all.
38 later devices descend from it; 4 cite it directly.
5 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082427: Syngo MR B17, Siemens Medical Solutions USA, Inc. (2008) Summary page 3.
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio, Siemens Medi Cal Solutions, Inc. (2012) Summary page 4.

## Most influential descendants
- K133226: Biograph MMR (2013), 20 descendants of its own
- K163234: Biograph mMR with syngo MR E11P system software (2017), 12 descendants of its own
- K132119: Magnetom Prisma, Magnetom Prisma Fit (2013), 12 descendants of its own
- K181371: uMR 790 (2018), 11 descendants of its own
- K191157: uMR 780, uMR 790 (2019), 10 descendants of its own

## Indications for use
The MAGNETOM systems, Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio with software syngo MR B19, are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display 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, Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio with software syngo MR B19, 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/K123938
Methodology: https://510kreport.com/methodology