510(k) Report

510(k) · Cleared

Cleared

Medrad Quad C-Spine Coil, 1.5T Model, M64CSC, 1.0T Model M42CSC

K982959510(k) TraditionalCleared Nov 3, 199871-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

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

Cleared on Nov 3, 1998 as substantially equivalent to K884369 (General Electric Co., 1988) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 1988.

Decided
Nov 3, 1998
Review
71 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K884369 (1988). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestorK884369 · Posterior Cervical Spine Surface Coil M1085AM · General Electric Co. · 19881985199019952000
Other ancestors, by generation 1 generation back: 1 other ancestor K884369 · Posterior Cervical Spine Surface Coil M1085AM · General Electric Co. · 19880
  1. Root · 1 generation backK884369 Posterior Cervical Spine Surface Coil M1085AMGeneral Electric Co. · 1988
  2. This deviceK982959 Medrad Quad C-Spine Coil, 1.5T Model, M64CSC, 1.0T Model M42CSCMedrad, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K884369Posterior Cervical Spine Surface Coil M1085AMGeneral Electric Co.1988—
0 (this device)K982959Medrad Quad C-Spine Coil, 1.5T Model, M64CSC, 1.0T Model M42CSCMedrad, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K982959, 1988–1998Source: 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), the FDA summary (predicates and indications), 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? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K884369Posterior Cervical Spine Surface Coil M1085AM
Summary page 2
…The following table compares the predicate GE Linear C-Spine Coil, the Hitachi 1.5T Quad C-Spine Coil and the proposed Medrad Quad C-Spine Coil. GE Linear C-Spine Coil (K884369) Hitachi Quad C-Spine Coil (K954952) Medrad Quad C-Spine Coil Receive-only linear coil. Receive-only Quadrature coil Receive…
General Electric Co.1988—
*K954952Medrad/Hitachi 1.5T Quad C-Spine Surface Coil
Summary page 2
…icate GE Linear C-Spine Coil, the Hitachi 1.5T Quad C-Spine Coil and the proposed Medrad Quad C-Spine Coil. GE Linear C-Spine Coil (K884369) Hitachi Quad C-Spine Coil (K954952) Medrad Quad C-Spine Coil Receive-only linear coil. Receive-only Quadrature coil Receive-only Quadrature coil. Region of int…
Medrad, Inc.1996—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 2 ancestors has a recall.

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—

What is it indicated for?

The Medrad Quad C-Spine Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the Area superior to the top of the sella turcica and inferior to the third thoracic vertebra

The Medrad Quad C-Spine Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Magnetic Resonance Imaging.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Medrad, Inc.

105 FDA decisions under this applicant name. See the company

  • K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc. · 20141 recall
  • K130381Angiojet Ultra Power Pulse KitMedrad, Inc. · 2013
  • K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System; Jetstream SC 1.6 SystemMedrad, Inc. · 2013
  • K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 SystemMedrad, Inc. · 2012
  • K113363Angiojet Solent Dista Thrombectomy SetMedrad, Inc. · 20121 recall

Recent decisions in LNH

The LNH category page

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https://510kreport.com/device/K982959 · printed Nov 5, 2026

Cite this page

510(k) Report. “K982959: Medrad Quad C-Spine Coil, 1.5T Model, M64CSC, 1.0T Model M42CSC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982959

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026