510(k) Report

510(k) · Cleared

Recalled · 2010

Hitachi Airis II

K001334510(k) TraditionalCleared Jul 6, 200070-day reviewClass II21 CFR 892.1000Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hitachi Medical Systems America, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jul 6, 2000 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 63 later devices descend from it. It has been recalled 3 times.

Decided
Jul 6, 2000
Review
70 days
Class
Class II
Product code
LNH
Recalls
3
Predicates
0

63 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2009: 6 descendants cleared2003: 3 descendants cleared2004: 1 descendant cleared2006: 5 descendants cleared2007: 1 descendant cleared2005: 2 descendants cleared2024: 3 descendants cleared2008: 5 descendants cleared2011: 4 descendants cleared2012: 7 descendants cleared2019: 4 descendants cleared2015: 4 descendants cleared2014: 1 descendant cleared2010: 2 descendants cleared2016: 3 descendants cleared2026: 5 descendants cleared2013: 3 descendants cleared2017: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK001334 Hitachi Airis IIHitachi Medical Systems America, Inc. · 2000
  2. Descendant · cites it directly · 45 of its ownK042236 G-SCANEsaote, S.p.A. · 2004
  3. Descendant · 2 generations on · 43 of its ownK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
  4. Descendant · 2 generations on · 34 of its ownK063207 S-Scan Mri SystemEsaote, S.p.A. · 2006
  5. Descendant · 3 generations on · 32 of its ownK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
  6. Descendant · 2 generations on · 24 of its ownK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008

Showing 5 of 63 descendants. See all descendants

Descendants cleared per year

2002: 12003: 32004: 12005: 22006: 52007: 12008: 52009: 62010: 22011: 42012: 72013: 32014: 12015: 42016: 32017: 12019: 42021: 12022: 12024: 32026: 5
2002high 7 (2012) · low 0 (2018)2026

Most influential descendants

Showing 5 of 63 · See all
  • K042236G-SCANEsaote, S.p.A. · 2004 · cites it directly45descendants
  • K060956G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006 · 2 generations on43descendants
  • K063207S-Scan Mri SystemEsaote, S.p.A. · 2006 · 2 generations on34descendants
  • K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006 · 3 generations on32descendants
  • K080968S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaEsaote, S.p.A. · 2008 · 2 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001334Hitachi Airis IIHitachi Medical Systems America, Inc.2000—
+1K042236G-SCANEsaote, S.p.A.2004—
+2K060956G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A.2006—
+2K063207S-Scan Mri SystemEsaote, S.p.A.2006—
+3K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A.2006—
+2K080968S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaEsaote, S.p.A.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200330
200410
200520
200650
200710
200850
200960
201020
201140
201270
201330
201410
201540
201630
201710
201940
202110
202210
202430
202650
FIG. 1 — Lineage of K001334, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (63)

See all 63

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042236G-SCANEsaote, S.p.A.200445
K092469O-Scan MR SystemEsaote, S.p.A.200918
K030918Superopen 0.35T, Model NSM-P035Neusoft Digital Medical Systems Co., Ltd.20038
K032232Airis Elite Magnetic Resonance Imaging DeviceHitachi Medical Systems America, Inc.20036
K092899Oper Series Open Type Permanent-Magnet Mri System, Model: Oper-0.3, -0.35, -0.4Ningbo Xingaoyi Magnetism Co., Ltd.20090
K090873I Open 0.5TBeijing Wandong Medical Equipment Co., Ltd.20090
K090433I_Open 0.4TBeijing Wandong Medical Equipment Co., Ltd.20090
K022390Hitachi AltaireHitachi Medical Systems America, Inc.20020

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 19, 2010Not classifiedZ-1616-2010OtherHitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a patient at risk.
Apr 25, 2006Not classifiedZ-1115-06OtherImproper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections.
Jun 30, 2005Not classifiedZ-0889-05OtherImage reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K042236 (Esaote, S.p.A., 2004) has gone furthest, with 45 descendants of its own.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

More from Hitachi Medical Systems America, Inc.

100 FDA decisions under this applicant name. See the company

  • K163528HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017
  • K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc. · 2016
  • K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016
  • K160152Trillium Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc. · 2016
  • K153547ECHELON Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc. · 20162 recalls

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The LNH category page

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https://510kreport.com/device/K001334 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001334: Hitachi Airis II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001334

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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