510(k) Report

510(k) · Cleared

Cleared

Motion Correction System

K193324510(k) TraditionalCleared Feb 4, 202064-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

Kineticor, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Feb 4, 2020 as substantially equivalent to K183254 (Siemens Medical Solutions USA, Inc., 2019) after a 64-day review. Its family tree reaches back 16 generations to 1997. 6 of the 41 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.

Decided
Feb 4, 2020
Review
64 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
1

Its longest line of descent runs back 16 generations to K971684 (1997). 38 ancestors in all, the oldest K932271 (1994). 2 later devices descend from it, 1 citing it directly. 6 of the 41 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2011: 2 other ancestors2009: 2 other ancestors2010: 1 other ancestor2005: 3 other ancestors2002: 2 other ancestors2007: 1 other ancestor2006: 1 other ancestor2000: 2 other ancestors1998: 1 other ancestor1994: 1 other ancestor2004: 1 other ancestor2001: 3 other ancestors1999: 2 other ancestors2021: 1 descendant cleared2022: 1 descendant clearedK971684 · Magnetom Project 047 System (Numaris 3.5 Software) · Siemens Medical Solutions USA, Inc. · 1997 · recalledK032428 · Magnetom Avanto MR System · Siemens Medical Solutions USA, Inc. · 2003 · recalledK041112 · Magnetom Espree System · Siemens Medical Solutions USA, Inc. · 2004 · recalledK052164 · Magnetom Systems with Software Syngo MR 2006A · Siemens Medical Solutions USA, Inc. · 2005K062454 · Magnetom Systems - I-Class and T-Class Releases · Siemens Medi Cal Solutions, Inc. · 2006K072237 · Magnetom Verio · Siemens Medical Solutions USA, Inc. · 2007 · Class I recallK082427 · Syngo MR B17 · Siemens Medical Solutions USA, Inc. · 2008K101347 · Magnetom Aera; Magnetom Skyra · Siemens Medical Solutions USA, Inc. · 2010 · Class I recallK111242 · Magnetom Aera and Magnetom Skyra · Siemens Medical Solutions USA, Inc. · 2011 · recalledK121434 · Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio · Siemens Medi Cal Solutions, Inc. · 2012 · Class I recallK141977 · Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel · Siemens Medical Solutions USA, Inc. · 2014K151579 · MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit · Siemens Medical Solutions USA, Inc. · 2015 · Class I recallK153343 · MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit · Siemens Medi Cal Solutions, Inc. · 2016 · Class I recallK170396 · MAGNETOM Vida · Siemens Medical Solutions USA, Inc. · 2017 · Class I recall×2: 2 generations cleared close together, K181433 (2018), K183254 (2019) 1990200020102020
Other ancestors, by generationDescendants, by generation 7 generations back: 2 other ancestors8 generations back: 5 other ancestors9 generations back: 8 other ancestors10 generations back: 6 other ancestors11 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K183254 · Magnetom Vida · Siemens Medical Solutions USA, Inc. · 2019K181433 · MAGNETOM Vida · Siemens Medical Solutions USA, Inc. · 2018K170396 · MAGNETOM Vida · Siemens Medical Solutions USA, Inc. · 2017 · Class I recallK153343 · MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit · Siemens Medi Cal Solutions, Inc. · 2016 · Class I recallK151579 · MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit · Siemens Medical Solutions USA, Inc. · 2015 · Class I recallK141977 · Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel · Siemens Medical Solutions USA, Inc. · 2014K121434 · Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio · Siemens Medi Cal Solutions, Inc. · 2012 · Class I recallK111242 · Magnetom Aera and Magnetom Skyra · Siemens Medical Solutions USA, Inc. · 2011 · recalledK101347 · Magnetom Aera; Magnetom Skyra · Siemens Medical Solutions USA, Inc. · 2010 · Class I recallK082427 · Syngo MR B17 · Siemens Medical Solutions USA, Inc. · 2008K072237 · Magnetom Verio · Siemens Medical Solutions USA, Inc. · 2007 · Class I recallK062454 · Magnetom Systems - I-Class and T-Class Releases · Siemens Medi Cal Solutions, Inc. · 2006K052164 · Magnetom Systems with Software Syngo MR 2006A · Siemens Medical Solutions USA, Inc. · 2005K041112 · Magnetom Espree System · Siemens Medical Solutions USA, Inc. · 2004 · recalledK032428 · Magnetom Avanto MR System · Siemens Medical Solutions USA, Inc. · 2003 · recalledK971684 · Magnetom Project 047 System (Numaris 3.5 Software) · Siemens Medical Solutions USA, Inc. · 1997 · recalled−15−10−50
  1. Root · 16 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
  2. 12 generations between
  3. 3 generations backK170396 MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · Recalled (Class I)
  4. 2 generations backK181433 MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2018
  5. 1 generation backK183254 Magnetom VidaSiemens Medical Solutions USA, Inc. · 2019
  6. This deviceK193324 Motion Correction SystemKineticor, Inc. · 2020
  7. Descendant · cites it directly · 1 of its ownK203451 TCL3 Motion Tracking SystemTracinnovations Aps · 2021
  8. Descendant · 2 generations on · 0 of its ownK221785 TCL3 Motion Tracking SystemTracinnovations A/S · 2022
Show all 16 generations
  1. Root · 16 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
  2. 15 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
  3. 14 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
  4. 13 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
  5. 12 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
  6. 11 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
  7. 10 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
  8. 9 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
  9. 8 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
  10. 7 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
  11. 6 generations backK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
  12. 5 generations backK151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit…Siemens Medical Solutions USA, Inc. · 2015 · Recalled (Class I)
  13. 4 generations backK153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · Recalled (Class I)
  14. 3 generations backK170396 MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · Recalled (Class I)
  15. 2 generations backK181433 MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2018
  16. 1 generation backK183254 Magnetom VidaSiemens Medical Solutions USA, Inc. · 2019
  17. This deviceK193324 Motion Correction SystemKineticor, Inc. · 2020

Class I recalls in this family

Most influential descendants

Showing 2 of 2 · See all
  • K203451TCL3 Motion Tracking SystemTracinnovations Aps · 2021 · cites it directly1descendant
  • K221785TCL3 Motion Tracking SystemTracinnovations A/S · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K971684Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc.19974
−15K032428Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc.20034
−14K041112Magnetom Espree SystemSiemens Medical Solutions USA, Inc.20044
−13K052164Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc.2005—
−12K062454Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc.2006—
−11K072237Magnetom VerioSiemens Medical Solutions USA, Inc.2007Class I
−10K082427Syngo MR B17Siemens Medical Solutions USA, Inc.2008—
−9K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc.2010Class I
−8K111242Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc.20113
−7K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc.2012Class I
−6K141977Magnetom 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
−4K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc.2016Class I
−3K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc.2017Class I
−2K181433MAGNETOM VidaSiemens Medical Solutions USA, Inc.2018—
−1K183254Magnetom VidaSiemens Medical Solutions USA, Inc.2019—
0 (this device)K193324Motion Correction SystemKineticor, Inc.2020—
+1K203451TCL3 Motion Tracking SystemTracinnovations Aps2021—
+2K221785TCL3 Motion Tracking SystemTracinnovations A/S2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199810
199920
200020
200130
200220
200410
200530
200610
200710
200920
201010
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202210
FIG. 1 — Lineage of K193324, 1997–2022Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

6 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
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K183254Magnetom Vida
Summary page 5
…Marketed Predicate Device (21 CFR §807.92(a)(3)) Trade Name: MAGNETOM Vida 510(k) Number: K183254 cleared January 18, 2019 Classification Name: Magnetic Resonance Diagnostic Device (MRDD)…
Siemens Medical Solutions USA, Inc.2019—

Also cleared against K183254: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K203451TCL3 Motion Tracking SystemTracinnovations Aps20211

Has anything in its family been recalled? (6 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.

  • K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 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 · 4 generations back · ◆ on the line of descent in 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 back · ◆ on the line of descent in FIG. 12 Class I recalls
  • K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 6 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
  • K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 8 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
  • K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 8 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
  • 17 of the 38 ancestors have a recall of any class; 6 have a Class I recall.
  • Of its descendants, K203451 (Tracinnovations Aps, 2021) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K183254.

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. 2020, this device’s year, is highlighted.

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—

What is it indicated for?

The Motion Correction System is an accessory to a Magnetic Resonance Imaging (MRI) scanner. The system is a sensor-based technology for tracking of patient movement during an MRI session. It provides the current position of the patient in real-time to the MRI scanner for further data processing.

User: Professional Use

Environment: Hospital, doctor’s office, or any facility that uses an MRI device

KinetiCor defines the Motion Correction System as an accessory to a medical device. It is intended to support, supplement and/or augment the performance of the MAGNETOM Skyra 3T MRI scanner.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K193324: Motion Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193324

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026