510(k) · Cleared
ClearedMyoStrain (6.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myocardial Solutions, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Aug 26, 2024 as substantially equivalent to K182756 (Myocardial Solutions, 2019) after an 83-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Aug 26, 2024
- Review
- 83 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K900889 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK900889 Magnetic Resonance Diagnostic Device AccessoriesSiemens Medical Solutions USA, Inc. · 1990
- 4 generations backK973799 Cardiac Tagging Techniques/Magnetom Vision and Magnetom ImpactSiemens Medical Solutions USA, Inc. · 1998
- 3 generations backK061368 Diagnosoft HarpDiagnosoft, Inc. · 2006
- 2 generations backK100352 Diagnosoft Harp Model 2.06Diagnosoft, Inc. · 2010
- 1 generation backK182756 MyoStrain 5.1Myocardial Solutions · 2019
- This deviceK241607 MyoStrain (6.0)Myocardial Solutions, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K900889 | Magnetic Resonance Diagnostic Device Accessories | Siemens Medical Solutions USA, Inc. | 1990 | — |
| −4 | K973799 | Cardiac Tagging Techniques/Magnetom Vision and Magnetom Impact | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −3 | K061368 | Diagnosoft Harp | Diagnosoft, Inc. | 2006 | — |
| −2 | K100352 | Diagnosoft Harp Model 2.06 | Diagnosoft, Inc. | 2010 | — |
| −1 | K182756 | MyoStrain 5.1 | Myocardial Solutions | 2019 | — |
| 0 (this device) | K241607 | MyoStrain (6.0) | Myocardial Solutions, Inc. | 2024 | — |
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.
Planning a device in LNH? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182756 | MyoStrain 5.1Summary page 4…ain Classification Name: Magnetic resonance diagnostic device (21 CFR 892.1000) Regulatory Class: II Product Code: LNH III. PREDICATE DEVICE MyoStrain (5.1.2) - K182756 IV. DEVICE DESCRIPTION The Myocardial Solutions Myostrain is software that runs on Windows-based operating systems to view… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- None of the 5 ancestors has a recall.
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. 2024, 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?
MyoStrain® software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing. Available measurements include…
Read the full statement (147 words)
MyoStrain® software is an image processing device that post-processes strain-encoded (SENC) images, which are acquired by MRI systems equipped with a SENC pulse sequence. MyoStrain software receives SENC images from MRI storage and archives, and performs extraction of time-resolved, quantitative strain information per voxel and other cardiac measurements, viewing, image manipulations, communications, and printing. Available measurements include longitudinal and circumferential strain to quantitatively describe the wall motion of the heart. Tools are provided to display regional motion properties of the heart. A report interface is provided. Measurement tools provide information that can be output in standardized or specialized report formats. This interface makes it possible to quickly and reliably fill out a complete clinical report of a cardiac imaging exam with strain. The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians to support the determination of a diagnosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241607 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241607: MyoStrain (6.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241607
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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