510(k) Report

510(k) · Cleared

Recalled · 2006

AIRIS

K945155510(k) TraditionalCleared May 24, 1995215-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 May 24, 1995 after a 215-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 51 later devices descend from it. It has been recalled 3 times.

Decided
May 24, 1995
Review
215 days
Class
Class II
Product code
LNH
Recalls
3
Predicates
0

51 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1999: 1 descendant cleared2004: 2 descendants cleared2002: 1 descendant cleared2003: 1 descendant cleared2006: 3 descendants cleared2005: 1 descendant cleared2008: 4 descendants cleared2011: 4 descendants cleared2009: 2 descendants cleared2013: 3 descendants cleared2012: 7 descendants cleared2010: 2 descendants cleared2016: 3 descendants cleared2019: 4 descendants cleared2015: 4 descendants cleared2017: 1 descendant cleared2021: 1 descendant cleared2026: 3 descendants cleared2022: 1 descendant cleared2024: 2 descendants cleared1995200020052010201520202025
  1. This deviceK945155 AIRISHitachi Medical Systems America, Inc. · 1995
  2. Descendant · cites it directly · 50 of its ownK981358 Artoscan SBiosound Esaote, Inc. · 1998
  3. Descendant · 2 generations on · 49 of its ownK990968 E-SCANBiosound Esaote, Inc. · 1999
  4. Descendant · 3 generations on · 48 of its ownK020164 E-Scan XQBiosound Esaote, Inc. · 2002
  5. Descendant · 3 generations on · 47 of its ownK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
  6. Descendant · 4 generations on · 45 of its ownK042236 G-SCANEsaote, S.p.A. · 2004

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12002: 12003: 12004: 22005: 12006: 32008: 42009: 22010: 22011: 42012: 72013: 32015: 42016: 32017: 12019: 42021: 12022: 12024: 22026: 3
1998high 7 (2012) · low 0 (2000)2026

Most influential descendants

Showing 5 of 51 · See all
  • K981358Artoscan SBiosound Esaote, Inc. · 1998 · cites it directly50descendants
  • K990968E-SCANBiosound Esaote, Inc. · 1999 · 2 generations on49descendants
  • K020164E-Scan XQBiosound Esaote, Inc. · 2002 · 3 generations on48descendants
  • K032121Modification to E-Scan XQEsaote, S.p.A. · 2003 · 3 generations on47descendants
  • K042236G-SCANEsaote, S.p.A. · 2004 · 4 generations on45descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945155AIRISHitachi Medical Systems America, Inc.1995—
+1K981358Artoscan SBiosound Esaote, Inc.1998—
+2K990968E-SCANBiosound Esaote, Inc.1999—
+3K020164E-Scan XQBiosound Esaote, Inc.2002—
+3K032121Modification to E-Scan XQEsaote, S.p.A.2003—
+4K042236G-SCANEsaote, S.p.A.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200210
200310
200420
200510
200630
200840
200920
201020
201140
201270
201330
201540
201630
201710
201940
202110
202210
202420
202630
FIG. 1 — Lineage of K945155, 1995–2026Source: 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? (51)

See all 51

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981358Artoscan SBiosound Esaote, Inc.199850

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 16, 2006Not classifiedZ-0029-2007OtherImage orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they…
Mar 17, 2006Not classifiedZ-1105-06OtherSoftware anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient…
Dec 1, 2005Not classifiedZ-0428-06OtherThe bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K981358 (Biosound Esaote, Inc., 1998) has gone furthest, with 50 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—

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https://510kreport.com/device/K945155 · printed Nov 5, 2026

Cite this page

510(k) Report. “K945155: AIRIS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945155

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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