Syngo MR B17

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 K072237: 8 other devices →

9 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.

• K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
• K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
• K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
• K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
• K121160Magnetom SpectraSiemens Medical Solutions USA, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
• K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
• K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
• K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
• K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
• K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
• K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
• K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls

Nearest 12 of 22 shown.

Nearest 5 of 22; all are on the web page.

What does this lineage say?

• The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
• 7 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
• Of its descendants, K101347 (Siemens Medical Solutions USA, Inc., 2010) has gone furthest, with 224 descendants of its own.
• 8 other devices also cite its predicate K072237.

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

What is it indicated for?

Indications for use as stated in the FDA summary.