510(k) · Cleared
Recalled · 2006Hitachi Altaire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Oct 11, 2002 as substantially equivalent to K001334 (Hitachi Medical Systems America, Inc., 2000) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1999. It has been recalled 5 times.
- Decided
- Oct 11, 2002
- Review
- 80 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992746 (1999). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK992746 Signa Hfo/I Magnetic Resonance SystemGe Medical Systems, Inc. · 1999 · Recalled
- This deviceK022390 Hitachi AltaireHitachi Medical Systems America, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992746 | Signa Hfo/I Magnetic Resonance System | Ge Medical Systems, Inc. | 1999 | 2 |
| 0 (this device) | K022390 | Hitachi Altaire | Hitachi Medical Systems America, Inc. | 2002 | — |
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? (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 |
|---|---|---|---|
| * | K001334 | Hitachi Airis II | 2000 |
| * | K992746 | Signa Hfo/I Magnetic Resonance SystemSummary page 1…maging System 2.4 Predicate Device(s): Hitachi AIRIS I1 MRI System (KO01 334) GE Signa Openspeed MRI System (K992746) 3.0 Device Intended Use The MR system is an imaging device and is intended to provide the physician with physi… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 21, 2006 | Not classified | Z-0910-06 | Other | The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures. |
| Jan 27, 2006 | Not classified | Z-1103-06 | Other | Circuit Failure-There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the system main breaker when 2 of the 3 power phases are lost. |
| Jun 30, 2005 | Not classified | Z-0888-05 | Other | Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder. |
| Apr 11, 2005 | Not classified | Z-0797-05 | Other | The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard. |
| Nov 18, 2004 | Not classified | Z-0846-05 | Other | The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- 7 other devices also cite its predicate K001334.
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 Altaire MR 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 (108 words)
The Altaire MR 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 (E), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022390 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022390: Hitachi Altaire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022390
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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