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 Sep 16, 2026 as substantially equivalent to K253862 (Fujifilm Corporation, 2026) after a 152-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Sep 16, 2026
- Review
- 152 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K974212 (1998). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK974212 Airis IIHitachi Medical Systems America, Inc. · 1998 · Recalled
- 3 generations backK032232 Airis Elite Magnetic Resonance Imaging DeviceHitachi Medical Systems America, Inc. · 2003 · Recalled
- 2 generations backK233629 APERTO Lucent MRI SystemFUJIFILM Healthcare Americas Corporation · 2024
- 1 generation backK253862 APERTO Lucent MRI SystemFujifilm Corporation · 2026
- This deviceK261283 APERTO Lucent MRI SystemFujifilm Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974212 | Airis II | Hitachi Medical Systems America, Inc. | 1998 | 5 |
| −3 | K032232 | Airis Elite Magnetic Resonance Imaging Device | Hitachi Medical Systems America, Inc. | 2003 | 2 |
| −2 | K233629 | APERTO Lucent MRI System | FUJIFILM Healthcare Americas Corporation | 2024 | — |
| −1 | K253862 | APERTO Lucent MRI System | Fujifilm Corporation | 2026 | — |
| 0 (this device) | K261283 | APERTO Lucent MRI System | Fujifilm Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K253862 | APERTO Lucent MRI SystemSummary page 6…ass 2 Panel Radiology Predicate Device Name Predicate Device(s): APERTO Lucent MRI system (K253862) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device P… | 2026 |
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 28 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 5 ancestors have a recall of any class.
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 (140 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 (Tl), 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:
• Tl, T2, proton density weighted imaging
• Diffusion weighted imaging
• MR Angiography
• Image processing
• Whole Body
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261283: 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/K261283
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026