Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel

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 K121434: 15 other devices →

7 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.

• K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
• K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 3 generations back · ◆ on the line of descent in 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
• K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · Cites it directly · ◆ 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 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
• K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 2 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 · 2 generations on · ◆ in the 2018 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
• K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
• K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc. · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls
• K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50ASiemens Medical Solutions USA, Inc. · 2022 · 6 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
• K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

Nearest 12 of 18 shown.

Nearest 5 of 18; all are on the web page.

What does this lineage say?

• The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
• 14 of the 32 ancestors have a recall of any class; 3 have a Class I recall.
• Of its descendants, K151579 (Siemens Medical Solutions USA, Inc., 2015) has gone furthest, with 85 descendants of its own.
• 15 other devices also cite its predicate K121434.

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

What is it indicated for?

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.