syngo.MR Applications

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Also cleared against K163294: 1 other device →

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

• K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 2 generations back · ◆ in the 2016 ancestors bar of FIG. 11 Class I recall
• K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
• K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
• K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · 3 generations back · ◆ in the 2015 ancestors bar of FIG. 12 Class I recalls
• K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

• The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
• 45 of the 190 ancestors have a recall of any class; 5 have a Class I recall.
• Of its descendants, K182904 (Siemens Medical Solutions USA, Inc., 2019) has gone furthest, with 14 descendants of its own.
• 1 other device also cites its predicate K163294.

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.