510(k) · Cleared
ClearedR2-Mri Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inner Vision Biometrics Pty, Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jan 21, 2005 as substantially equivalent to K994283 (Medis Medical Imaging Systems BV, 2000) and 1 other predicate after a 56-day review. Its family tree reaches back 3 generations to 1994. 7 later devices descend from it.
- Decided
- Jan 21, 2005
- Review
- 56 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940172 (1994). 4 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 2 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 1 generation backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- This deviceK043271 R2-Mri Analysis SystemInner Vision Biometrics Pty, Ltd. · 2005
- Descendant · cites it directly · 3 of its ownK122035 Hepafat ScanResonance Health Analysis Services Pty, Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK201039 HepaFat-AIResonance Health Analysis Services Pty, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK213960 LiverMultiScan v5 (LMSv5)Perspectum · 2022
- Descendant · 2 generations on · 0 of its ownK253413 LiverMultiScan (v6.0)Perspectum, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK231459 HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K122035Hepafat ScanResonance Health Analysis Services Pty, Ltd. · 2013 · cites it directly3descendants
- K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd. · 2020 · 2 generations on2descendants
- K213960LiverMultiScan v5 (LMSv5)Perspectum · 2022 · cites it directly1descendant
- K253413LiverMultiScan (v6.0)Perspectum, Ltd. · 2026 · 2 generations on0descendants
- K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −2 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −1 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| 0 (this device) | K043271 | R2-Mri Analysis System | Inner Vision Biometrics Pty, Ltd. | 2005 | — |
| +1 | K122035 | Hepafat Scan | Resonance Health Analysis Services Pty, Ltd. | 2013 | — |
| +2 | K201039 | HepaFat-AI | Resonance Health Analysis Services Pty, Ltd. | 2020 | — |
| +1 | K213960 | LiverMultiScan v5 (LMSv5) | Perspectum | 2022 | — |
| +2 | K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | 2026 | — |
| +2 | K231459 | HepaFatSmart (V2.0.0) | Resonance Health Analysis Services Pty, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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.
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? (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 |
|---|---|---|---|
| * | K994283 | Mri- Magnetic Resonance Analytical Software SystemSummary page 2…tem § ' 4' PREDICATE DEVICE(S): K994283: Medis, MRI (Magnetic resonance Analytical Software System)… | 2000 |
| * | K961969 | Hitachi Stratis, MRH-1500 Magnetic Resonance Diagnostic Devices Version 6 Operating…Summary page 2…283: Medis, MRI (Magnetic resonance Analytical Software System) K961969: Hitachi, Magnetic Resonance Diagnostic Device Version 6 O… | 1996 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K122035 (Resonance Health Analysis Services Pty, Ltd., 2013) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K994283.
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.
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?
The R2-MRI Analysis System is an accessory diagnostic device to MRI scanners and is intended for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043271 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043271: R2-Mri Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043271
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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