510(k) Report

510(k) · Cleared

Cleared

Profile 7000 C-Spine Coil

K943440510(k) TraditionalCleared Oct 6, 1995445-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

Us Asia Instruments, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Oct 6, 1995 after a 445-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 30 later devices descend from it.

Decided
Oct 6, 1995
Review
445 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
0

30 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1997: 3 descendants cleared1999: 1 descendant cleared2000: 1 descendant cleared2002: 2 descendants cleared2003: 1 descendant cleared2008: 1 descendant cleared2010: 1 descendant cleared2016: 6 descendants cleared2015: 3 descendants cleared2013: 1 descendant cleared2018: 1 descendant cleared2017: 2 descendants cleared2019: 1 descendant cleared2023: 2 descendants cleared2021: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK943440 Profile 7000 C-Spine CoilUs Asia Instruments, Inc. · 1995
  2. Descendant · cites it directly · 26 of its ownK971246 Leo 7000 Quadrature Knee CoilUsa Instruments, Inc. · 1997
  3. Descendant · 2 generations on · 22 of its ownK023982 Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist…Usa Instruments, Inc. · 2003
  4. Descendant · 3 generations on · 21 of its ownK082636 TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics · 2008 · Recalled
  5. Descendant · 4 generations on · 12 of its ownK100141 14-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2010
  6. Descendant · 5 generations on · 11 of its ownK130262 Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

1997: 31999: 12000: 12002: 22003: 12008: 12010: 12013: 12015: 32016: 62017: 22018: 12019: 12021: 12022: 12023: 22025: 12026: 1
1997high 6 (2016) · low 0 (1998)2026

Most influential descendants

Showing 5 of 30 · See all
  • K971246Leo 7000 Quadrature Knee CoilUsa Instruments, Inc. · 1997 · cites it directly26descendants
  • K023982Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist CoilUsa Instruments, Inc. · 2003 · 2 generations on22descendants
  • K082636TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics · 2008 · 3 generations on21descendants
  • K10014114-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2010 · 4 generations on12descendants
  • K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013 · 5 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943440Profile 7000 C-Spine CoilUs Asia Instruments, Inc.1995—
+1K971246Leo 7000 Quadrature Knee CoilUsa Instruments, Inc.1997—
+2K023982Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist CoilUsa Instruments, Inc.2003—
+3K082636TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics20088
+4K10014114-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc.2010—
+5K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199730
199910
200010
200220
200310
200810
201010
201310
201530
201660
201720
201810
201910
202110
202210
202320
202510
202610
FIG. 1 — Lineage of K943440, 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
Get a 510(k) Report

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? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K971246Leo 7000 Quadrature Knee CoilUsa Instruments, Inc.199726
K964753Matrix 3000 Flexible Spine CoilUs Asia Instruments, Inc.19971
K964820Maxim 7000 Quadrature Extremity Coil Model Number Qec-Gem-15AUs Asia Instruments, Inc.19970

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, K971246 (Usa Instruments, Inc., 1997) has gone furthest, with 26 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 Us Asia Instruments, Inc.

4 FDA decisions under this applicant name. See the company

  • K964820Maxim 7000 Quadrature Extremity Coil Model Number Qec-Gem-15AUs Asia Instruments, Inc. · 1997
  • K964753Matrix 3000 Flexible Spine CoilUs Asia Instruments, Inc. · 1997
  • K964531Profile 70000 Quadrature Volume Neck CoilUs Asia Instruments, Inc. · 1997

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The LNH category page

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https://510kreport.com/device/K943440 · printed Nov 4, 2026

Cite this page

510(k) Report. “K943440: Profile 7000 C-Spine Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943440

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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