510(k) · Cleared
Recalled · 2008Hitachi 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 17, 2000 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it. It has been recalled 8 times.
- Decided
- Oct 17, 2000
- Review
- 70 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 8
- Predicates
- 0
19 later devices descend from it, 2 citing it directly.
- This deviceK002420 Hitachi AltaireHitachi Medical Systems America, Inc. · 2000
- Descendant · cites it directly · 17 of its ownK050602 AltaireHitachi Medical Systems America, Inc. · 2005
- Descendant · 2 generations on · 16 of its ownK052172 HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 11 of its ownK083533 Echelon C Mri SystemHitachi Medical Systems America, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 10 of its ownK113145 Echelon Oval Mri SystemHitachi Medical Systems America, Inc. · 2012 · Recalled
- Descendant · 5 generations on · 6 of its ownK151015 ECHELON Oval V 5.0 MRI SystemHitachi Medical Systems America, Inc. · 2015 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K050602AltaireHitachi Medical Systems America, Inc. · 2005 · cites it directly17descendants
- K052172HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · 2 generations on16descendants
- K083533Echelon C Mri SystemHitachi Medical Systems America, Inc. · 2009 · 3 generations on11descendants
- K113145Echelon Oval Mri SystemHitachi Medical Systems America, Inc. · 2012 · 4 generations on10descendants
- K151015ECHELON Oval V 5.0 MRI SystemHitachi Medical Systems America, Inc. · 2015 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002420 | Hitachi Altaire | Hitachi Medical Systems America, Inc. | 2000 | — |
| +1 | K050602 | Altaire | Hitachi Medical Systems America, Inc. | 2005 | — |
| +2 | K052172 | HHF1 Magnetic Resonance Imaging System | Hitachi Medical Systems America, Inc. | 2005 | 3 |
| +3 | K083533 | Echelon C Mri System | Hitachi Medical Systems America, Inc. | 2009 | 2 |
| +4 | K113145 | Echelon Oval Mri System | Hitachi Medical Systems America, Inc. | 2012 | 3 |
| +5 | K151015 | ECHELON Oval V 5.0 MRI System | Hitachi Medical Systems America, Inc. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (19)
See all 192 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 11, 2008 | Not classified | Z-1542-2008 | Component design/selection | The firm's Altaire MR Scanner's Emergency Rundown Switch Unit (ERDU), that is used to shut down the device in an emergency, was found to be defective. An ERDU failure could delay or prevent patient access leading to possible patient death… |
| Jul 30, 2007 | Not classified | Z-1263-2007 | Other | Overheating; A portion (balun assembly) of the cable that connects the shoulder coil to the actual MRI unit may malfunction and result in overheating of the balun assembly. The overheating of the balun assembly could result in injury to… |
| Apr 28, 2006 | Not classified | Z-1104-06 | Other | Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis. |
| 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. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050602 (Hitachi Medical Systems America, Inc., 2005) has gone furthest, with 17 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.
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 | — |
https://510kreport.com/device/K002420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002420: Hitachi Altaire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002420
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026