510(k) · Cleared
ClearedMedrad Quadrature CTL Array Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jan 12, 1999 as substantially equivalent to K954952 (Medrad, Inc., 1996) and 2 other predicates after a 54-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jan 12, 1999
- Review
- 54 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K892235 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K892235 | GE Shoulder Surface Coil, Cat. #M1085AN | General Electric Co. | 1989 | — |
| −1 | K960901 | Medrad Phased Array 1.5T Shoulder Imaging Surface Coil | Medrad, Inc. | 1996 | — |
| 0 (this device) | K984159 | Medrad Quadrature CTL Array Coil | Medrad, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
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 MOS? 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 MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954952 | Medrad/Hitachi 1.5T Quad C-Spine Surface CoilSummary page 2…ims made in regard to the Hitachi Quad C-Spine Coil and the Page 2 of 3 Medrad Quad CTL Caoil. Hitachi Quad C-Spine GE Quad T/L w/ Medrad PA Medrad Quad CTL Coil Coil (K954952) Positioner Coil ShoulderCoil (K902663) (K960901) Receive-only Quadrature Receive-only Receive-only, Receive-only, Phased coil Qu… | 1996 |
| * | K902663 | GE Quadrature T/L Spine Surf Coil, M1085AP/M1285APSummary page 2…C-Spine Coil and the Page 2 of 3 Medrad Quad CTL Caoil. Hitachi Quad C-Spine GE Quad T/L w/ Medrad PA Medrad Quad CTL Coil Coil (K954952) Positioner Coil ShoulderCoil (K902663) (K960901) Receive-only Quadrature Receive-only Receive-only, Receive-only, Phased coil Quadrature coil Phased Array Coll Array Q… | 1990 |
| * | K960901 | Medrad Phased Array 1.5T Shoulder Imaging Surface CoilSummary page 2…il and the Page 2 of 3 Medrad Quad CTL Caoil. Hitachi Quad C-Spine GE Quad T/L w/ Medrad PA Medrad Quad CTL Coil Coil (K954952) Positioner Coil ShoulderCoil (K902663) (K960901) Receive-only Quadrature Receive-only Receive-only, Receive-only, Phased coil Quadrature coil Phased Array Coll Array Quadrature… | 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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K954952.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The Medrad Quad CTL Array Coil is a receive only coil intended to be used MRI Scanncr Systems for imaging of the cervical, thoracic and lumbar regions of the spinc anatomy.
The Medrad Quad CTI. Array Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Magnetic Resonance I'naging.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984159 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984159: Medrad Quadrature CTL Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984159
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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