# K130749: Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 20, 2013 after 154 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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). 33 ancestors in all.
54 later devices descend from it; 7 cite it directly.
3 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio, Siemens Medi Cal Solutions, Inc. (2012) Summary page 4.
- K123375: Syngo.Via, Siemens AG (2012) Summary page 4.

## Most influential descendants
- K133401: Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR General (2014), 27 descendants of its own
- K151353: syngo.MR Neurology, syngo.MR Oncology (2015), 25 descendants of its own
- K163294: syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology (2017), 23 descendants of its own
- K180336: syngo.MR Applications (2018), 21 descendants of its own
- K152602: Olea Sphere V3.0 (2016), 17 descendants of its own

## Indications for use
The software comprising the syngo.MR post-processing applications are post-processing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use. syngo.MR General is a syngo based post-processing software for viewing, manipulating, and evaluating MR images. syngo.MR Cardiology is a syngo based post-processing software for viewing, manipulating, and evaluating MR cardiac images. syngo.MR Vascular is a syngo based post-processing software for viewing, manipulating, and evaluating MR vascular images.

Source page: https://510kreport.com/device/K130749
Methodology: https://510kreport.com/methodology