510(k) Report

510(k) · Cleared

Cleared

Model #801GE1500 Pediatric Array Coil

K951649510(k) TraditionalCleared Jun 22, 199573-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

Medic, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jun 22, 1995 after a 73-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Jun 22, 1995
Review
73 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 2 descendants cleared2014: 1 descendant cleared2019: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951649 Model #801GE1500 Pediatric Array CoilMedic, Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK133986 1.5T Orbit and Mandible Array, 3.0T Orbit and Mandible ArrayResonance Innovations, LLC · 2014
  3. Descendant · 2 generations on · 0 of its ownK183186 Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular…Shanghai United Imaging Healthcare Co., Ltd. · 2019
  4. Descendant · cites it directly · 0 of its ownK061170 3.0T Pediatric Head and Spine Array, Model 808GE3000Resonance Innovations, LLC · 2006
  5. Descendant · cites it directly · 0 of its ownK060689 1.5T Pediatric Head and Spine Array ModelResonance Innovations, LLC · 2006

Most influential descendants

Showing 4 of 4 · See all
  • K1339861.5T Orbit and Mandible Array, 3.0T Orbit and Mandible ArrayResonance Innovations, LLC · 2014 · cites it directly1descendant
  • K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd. · 2019 · 2 generations on0descendants
  • K0611703.0T Pediatric Head and Spine Array, Model 808GE3000Resonance Innovations, LLC · 2006 · cites it directly0descendants
  • K0606891.5T Pediatric Head and Spine Array ModelResonance Innovations, LLC · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951649Model #801GE1500 Pediatric Array CoilMedic, Inc.1995—
+1K1339861.5T Orbit and Mandible Array, 3.0T Orbit and Mandible ArrayResonance Innovations, LLC2014—
+2K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil…Shanghai United Imaging Healthcare Co., Ltd.2019—
+1K0611703.0T Pediatric Head and Spine Array, Model 808GE3000Resonance Innovations, LLC2006—
+1K0606891.5T Pediatric Head and Spine Array ModelResonance Innovations, LLC2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
201410
201910
FIG. 1 — Lineage of K951649, 1995–2019Source: 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? (4)

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

NumberDeviceApplicantDecidedDescendants
K1339861.5T Orbit and Mandible Array, 3.0T Orbit and Mandible ArrayResonance Innovations, LLC20141
K0611703.0T Pediatric Head and Spine Array, Model 808GE3000Resonance Innovations, LLC20060
K0606891.5T Pediatric Head and Spine Array ModelResonance Innovations, LLC20060

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, K133986 (Resonance Innovations, LLC, 2014) has gone furthest, with 1 descendant 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 Medic, Inc.

12 FDA decisions under this applicant name. See the company

  • K0223951.5T Scanmed PV ArrayMedic, Inc. · 2002
  • K942874Model #300TO3500 Shoulder CoilMedic, Inc. · 1994
  • K942873Model #700TO3500 Neck/Abdominal CoilMedic, Inc. · 1994
  • K942875Model #900TO3500 Head/Neck CoilMedic, Inc. · 1994
  • K942355Model #310T03500 Wrist CoilMedic, Inc. · 1994

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https://510kreport.com/device/K951649 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951649: Model #801GE1500 Pediatric Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951649

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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