510(k) Report

510(k) · Cleared

Cleared

Magnetic Reson Diag Device Magnetom Project 016

K932271510(k) TraditionalCleared Jan 7, 1994254-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Medical Solutions USA, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jan 7, 1994 after a 254-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 of the 221 devices in its family, counting itself, have a Class I recall. 220 later devices descend from it.

Decided
Jan 7, 1994
Review
254 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
0

220 later devices descend from it, 1 citing it directly. 19 of the 221 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2002: 1 descendant cleared2003: 1 descendant cleared2009: 1 descendant cleared2012: 2 descendants cleared, 1 with a Class I recall12014: 7 descendants cleared2018: 18 descendants cleared, 2 with a Class I recall22013: 11 descendants cleared, 2 with a Class I recall22016: 5 descendants cleared, 1 with a Class I recall12019: 19 descendants cleared, 1 with a Class I recall12017: 15 descendants cleared, 1 with a Class I recall12015: 7 descendants cleared, 1 with a Class I recall12024: 18 descendants cleared2020: 21 descendants cleared, 3 with a Class I recall32022: 21 descendants cleared, 2 with a Class I recall22025: 20 descendants cleared, 1 with a Class I recall12023: 25 descendants cleared, 3 with a Class I recall32021: 9 descendants cleared, 1 with a Class I recall12026: 19 descendants cleared1990200020102020
  1. This deviceK932271 Magnetic Reson Diag Device Magnetom Project 016Siemens Medical Solutions USA, Inc. · 1994
  2. Descendant · cites it directly · 219 of its ownK021262 Magnetom Symphony Quadrature TX/RX Head CoilUsa Instruments, Inc. · 2002
  3. Descendant · 2 generations on · 217 of its ownK091114 TXRX 1.5T CP Head Coil; TXRX 3T CP Head CoilQuality Electrodynamics · 2009
  4. Descendant · 3 generations on · 215 of its ownK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
  5. Descendant · 4 generations on · 115 of its ownK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
  6. Descendant · 5 generations on · 85 of its ownK151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit…Siemens Medical Solutions USA, Inc. · 2015 · Recalled (Class I)

Showing 5 of 220 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12009: 12012: 22013: 112014: 72015: 72016: 52017: 152018: 182019: 192020: 212021: 92022: 212023: 252024: 182025: 202026: 19
2002high 25 (2023) · low 0 (2004)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 220 · See all
  • K021262Magnetom Symphony Quadrature TX/RX Head CoilUsa Instruments, Inc. · 2002 · cites it directly219descendants
  • K091114TXRX 1.5T CP Head Coil; TXRX 3T CP Head CoilQuality Electrodynamics · 2009 · 2 generations on217descendants
  • K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 3 generations on215descendants
  • K141977Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Siemens Medical Solutions USA, Inc. · 2014 · 4 generations on115descendants
  • K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma…Siemens Medical Solutions USA, Inc. · 2015 · 5 generations on85descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932271Magnetic Reson Diag Device Magnetom Project 016Siemens Medical Solutions USA, Inc.1994—
+1K021262Magnetom Symphony Quadrature TX/RX Head CoilUsa Instruments, Inc.2002—
+2K091114TXRX 1.5T CP Head Coil; TXRX 3T CP Head CoilQuality Electrodynamics2009—
+3K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc.2012Class I
+4K141977Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo…Siemens Medical Solutions USA, Inc.2014—
+5K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM…Siemens Medical Solutions USA, Inc.2015Class I

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200910
201221
2013112
201470
201571
201651
2017151
2018182
2019191
2020213
202191
2022212
2023253
2024180
2025201
2026190
FIG. 1 — Lineage of K932271, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

19 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LNH device

  1. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (220)

See all 220

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021262Magnetom Symphony Quadrature TX/RX Head CoilUsa Instruments, Inc.2002219

Has anything in its family been recalled? (19 Class I)

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 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
  • K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
  • K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
  • K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · 5 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 · 5 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 · 5 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 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
  • K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 6 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 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
  • K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
  • K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc. · 2019 · 8 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 · 9 generations on · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls

Nearest 12 of 19 shown.

What does this lineage say?

  • Of its descendants, K021262 (Usa Instruments, Inc., 2002) has gone furthest, with 219 descendants of its own.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—
Cite this page

510(k) Report. “K932271: Magnetic Reson Diag Device Magnetom Project 016.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K932271

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026