510(k) · Cleared
ClearedAPERTO Lucent MRI System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Apr 6, 2026 as substantially equivalent to K233629 (FUJIFILM Healthcare Americas Corporation, 2024) after a 124-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Apr 6, 2026
- Review
- 124 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K974212 (1998). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK974212 Airis IIHitachi Medical Systems America, Inc. · 1998 · Recalled
- 2 generations backK032232 Airis Elite Magnetic Resonance Imaging DeviceHitachi Medical Systems America, Inc. · 2003 · Recalled
- 1 generation backK233629 APERTO Lucent MRI SystemFUJIFILM Healthcare Americas Corporation · 2024
- This deviceK253862 APERTO Lucent MRI SystemFujifilm Corporation · 2026
- Descendant · cites it directly · 0 of its ownK261283 APERTO Lucent MRI SystemFujifilm Corporation · 2026
Most influential descendants
Showing 1 of 1 · See all- K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974212 | Airis II | Hitachi Medical Systems America, Inc. | 1998 | 5 |
| −2 | K032232 | Airis Elite Magnetic Resonance Imaging Device | Hitachi Medical Systems America, Inc. | 2003 | 2 |
| −1 | K233629 | APERTO Lucent MRI System | FUJIFILM Healthcare Americas Corporation | 2024 | — |
| 0 (this device) | K253862 | APERTO Lucent MRI System | Fujifilm Corporation | 2026 | — |
| +1 | K261283 | APERTO Lucent MRI System | Fujifilm Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K233629 | APERTO Lucent MRI SystemSummary page 6…ass 2 Panel Radiology Predicate Device Name Predicate Device(s): APERTO Lucent MRI system (K233629) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device P… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261283 | APERTO Lucent MRI System | 2026 | 0 |
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 28 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K261283 (Fujifilm Corporation, 2026) has gone furthest, with 0 descendants of its own.
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. 2026, 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?
The APERTO Lucent System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen…
Read the full statement (137 words)
The APERTO Lucent System is an imaging device, and is intended to provide the physician with
physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The
MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the
internal structure of the head, body, or extremities. The images produced by the MR system reflect the
spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that
determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation
time (T2) and flow. When interpreted by a trained physician, these images provide information that can be
useful in diagnosis determination.
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses:
• T1, T2, proton density weighted imaging
• Diffusion weighted imaging
• MR Angiography
• Image processing
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/K253862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253862: APERTO Lucent MRI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253862
Report an extraction error
Are you the manufacturer?
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