510(k) Report

510(k) · Cleared

Cleared

Model #QWH-63, Quadrature Wrist and Hand Coil

K931008510(k) TraditionalCleared Jun 18, 1993112-day reviewClass II21 CFR 892.1000

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

Mri Devices Corp. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jun 18, 1993 after a 112-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 81 later devices descend from it.

Decided
Jun 18, 1993
Review
112 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
0

81 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared1998: 1 descendant cleared2002: 2 descendants cleared2003: 3 descendants cleared2007: 1 descendant cleared2004: 2 descendants cleared2008: 6 descendants cleared2006: 3 descendants cleared1999: 1 descendant cleared2005: 1 descendant cleared2011: 4 descendants cleared2010: 3 descendants cleared2016: 9 descendants cleared2015: 7 descendants cleared2012: 8 descendants cleared2009: 2 descendants cleared2013: 4 descendants cleared2019: 5 descendants cleared2017: 3 descendants cleared2021: 2 descendants cleared2018: 1 descendant cleared2026: 4 descendants cleared2022: 2 descendants cleared2023: 2 descendants cleared2024: 2 descendants cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK931008 Model #QWH-63, Quadrature Wrist and Hand CoilMri Devices Corp. · 1993
  2. Descendant · cites it directly · 51 of its ownK963262 Artoscan MBiosound, Inc. · 1997
  3. Descendant · 2 generations on · 50 of its ownK981358 Artoscan SBiosound Esaote, Inc. · 1998
  4. Descendant · 3 generations on · 49 of its ownK990968 E-SCANBiosound Esaote, Inc. · 1999
  5. Descendant · 2 generations on · 48 of its ownK020164 E-Scan XQBiosound Esaote, Inc. · 2002
  6. Descendant · 2 generations on · 47 of its ownK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

1997: 21998: 11999: 12002: 22003: 32004: 22005: 12006: 32007: 12008: 62009: 22010: 32011: 42012: 82013: 42015: 72016: 92017: 32018: 12019: 52021: 22022: 22023: 22024: 22025: 12026: 4
1997high 9 (2016) · low 0 (2000)2026

Most influential descendants

Showing 5 of 81 · See all
  • K963262Artoscan MBiosound, Inc. · 1997 · cites it directly51descendants
  • K981358Artoscan SBiosound Esaote, Inc. · 1998 · 2 generations on50descendants
  • K990968E-SCANBiosound Esaote, Inc. · 1999 · 3 generations on49descendants
  • K020164E-Scan XQBiosound Esaote, Inc. · 2002 · 2 generations on48descendants
  • K032121Modification to E-Scan XQEsaote, S.p.A. · 2003 · 2 generations on47descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931008Model #QWH-63, Quadrature Wrist and Hand CoilMri Devices Corp.1993—
+1K963262Artoscan MBiosound, Inc.1997—
+2K981358Artoscan SBiosound Esaote, Inc.1998—
+3K990968E-SCANBiosound Esaote, Inc.1999—
+2K020164E-Scan XQBiosound Esaote, Inc.2002—
+2K032121Modification to E-Scan XQEsaote, S.p.A.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
199910
200220
200330
200420
200510
200630
200710
200860
200920
201030
201140
201280
201340
201570
201690
201730
201810
201950
202120
202220
202320
202420
202510
202640
FIG. 1 — Lineage of K931008, 1993–2026Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (81)

See all 81

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

NumberDeviceApplicantDecidedDescendants
K963262Artoscan MBiosound, Inc.199751
K972205Alpha 7000 Quadrature Wrist CoilUsa Instruments, Inc.199728

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?

  • Of its descendants, K963262 (Biosound, Inc., 1997) has gone furthest, with 51 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 Mri Devices Corp.

71 FDA decisions under this applicant name. See the company

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  • K040349Modification to HRW-127 Wrist Array CoilMri Devices Corp. · 2004
  • K040348Modification to HNC-127-Int Neurovascular Array CoilMri Devices Corp. · 2004
  • K040288QSC-127-Int Shoulder Array Coil SetMri Devices Corp. · 2004

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https://510kreport.com/device/K931008 · printed Nov 5, 2026

Cite this page

510(k) Report. “K931008: Model #QWH-63, Quadrature Wrist and Hand Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K931008

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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