510(k) · Cleared
ClearedMR Elastography; MZEK-001A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Medical Systems Corporation · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 3, 2022 as substantially equivalent to K140666 (Philips Medical Systems Nederland B.V., 2014) and 1 other predicate after a 57-day review. Its family tree reaches back 14 generations to 1995. 11 of the 148 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 3, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K935595 (1995). 147 ancestors in all, the oldest K891689 (1989). No later device cites it as a predicate yet. 11 of the 148 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations between
- 3 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 2 generations backK083421 MR-Touch OptionGe Medical Systems, LLC · 2009
- 1 generation backK140666 MR ElastographyPhilips Medical Systems Nederland B.V. · 2014
- This deviceK220018 MR Elastography; MZEK-001ACanon Medical Systems Corporation · 2022
Show all 14 generations
- Root · 14 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 13 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 12 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 11 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 10 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 9 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 8 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 5 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 4 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 2 generations backK083421 MR-Touch OptionGe Medical Systems, LLC · 2009
- 1 generation backK140666 MR ElastographyPhilips Medical Systems Nederland B.V. · 2014
- This deviceK220018 MR Elastography; MZEK-001ACanon Medical Systems Corporation · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −13 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −12 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −11 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −10 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −9 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −8 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −5 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −4 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −2 | K083421 | MR-Touch Option | Ge Medical Systems, LLC | 2009 | — |
| −1 | K140666 | MR Elastography | Philips Medical Systems Nederland B.V. | 2014 | — |
| 0 (this device) | K220018 | MR Elastography; MZEK-001A | Canon Medical Systems Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 1999 | 9 | 0 |
| 2000 | 9 | 0 |
| 2001 | 13 | 1 |
| 2002 | 10 | 1 |
| 2003 | 11 | 1 |
| 2004 | 14 | 2 |
| 2005 | 15 | 2 |
| 2006 | 7 | 0 |
| 2007 | 3 | 2 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 1 |
| 2011 | 4 | 0 |
| 2012 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
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.
11 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 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140666 | MR ElastographySummary page 5…c Resonance Diagnostic Device) 13. PRODUCT CODE 90-LNH 14. PREDICATE DEVICE Predicate Device: • MR Elastography (K140666) Reference Devices: • Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Syst… | 2014 |
| * | K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsSummary page 5…• MR Elastography (K140666) Reference Devices: • Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K193215) • MR Elastography, Resoundant (K201389) Subject Device… | 2020 |
| † | K201389 | Resoundant Acoustic Driver System | 2020 |
| † | K103411 | Ideal IQ Software Option | 2011 |
| † | K083421 | MR-Touch Option | 2009 |
| † | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | 2012 |
| † | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A… | 2014 |
| † | K211633 | Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR | 2021 |
| † | K203053 | Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR | 2020 |
| † | K212056 | Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (11 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 · 2 generations back · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 4 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- K063559Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · 4 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 4 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 5 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 5 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 6 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 55 of the 147 ancestors have a recall of any class; 11 have a Class I recall.
- 1 other device also cites its predicate K140666.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
MR Elastography is an optional package for Canon Medical Systems magnetic resonance imaging (MRI) systems. This option allows the user to obtain an image that reflects the stiffness, in kPa, of body tissue such as liver and muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220018: MR Elastography; MZEK-001A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220018
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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