510(k) · Cleared
ClearedMedrad Neurovascular 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 Jun 18, 1998 after an 84-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jun 18, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK981094 Medrad Neurovascular CoilMedrad, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK984257 Medrad Phased Array Neurovascular CoilMedrad, Inc. · 1999
- Descendant · 2 generations on · 2 of its ownK023596 Medrad 8-Receiver Phased Array Neurovascular CoilMedrad, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK093689 1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for SiemansMr Medical Solutions, LLC · 2010
- Descendant · 3 generations on · 0 of its ownK052827 Modification to Medrad 8-Receiver Phased Array Neurovascular Coil…Medrad, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K984257Medrad Phased Array Neurovascular CoilMedrad, Inc. · 1999 · cites it directly3descendants
- K023596Medrad 8-Receiver Phased Array Neurovascular CoilMedrad, Inc. · 2002 · 2 generations on2descendants
- K0936891.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for SiemansMr Medical Solutions, LLC · 2010 · 3 generations on0descendants
- K052827Modification to Medrad 8-Receiver Phased Array Neurovascular Coil for SiemensMedrad, Inc. · 2005 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981094 | Medrad Neurovascular Coil | Medrad, Inc. | 1998 | — |
| +1 | K984257 | Medrad Phased Array Neurovascular Coil | Medrad, Inc. | 1999 | — |
| +2 | K023596 | Medrad 8-Receiver Phased Array Neurovascular Coil | Medrad, Inc. | 2002 | — |
| +3 | K093689 | 1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for Siemans | Mr Medical Solutions, LLC | 2010 | — |
| +3 | K052827 | Modification to Medrad 8-Receiver Phased Array Neurovascular Coil for Siemens | Medrad, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | General Electric (GE) Quadrature Head Coil Named without a submission number | |
| * | — | GE Anterior Neck Coil Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984257 | Medrad Phased Array Neurovascular Coil | 1999 | 3 |
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, K984257 (Medrad, Inc., 1999) has gone furthest, with 3 descendants of its own.
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 Neurovascular Coil is a quadrature transmit/receive coil intended to
be used MRI Scanner Systems for imaging of the brain, skull base, and soft
tissues of the neck and upper chest, including the carotid arteries and attendant
vascular system.
The Medrad Neurovascular 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.
https://510kreport.com/device/K981094 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981094: Medrad Neurovascular Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981094
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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