510(k) · Cleared
ClearedMedrad Phased Array 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 Jan 25, 1999 as substantially equivalent to K981094 (Medrad, Inc., 1998) and 1 other predicate after a 56-day review. Its family tree reaches back 2 generations to 1989. 3 later devices descend from it.
- Decided
- Jan 25, 1999
- Review
- 56 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K892235 (1989). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK892235 GE Shoulder Surface Coil, Cat. #M1085ANGeneral Electric Co. · 1989
- 1 generation backK960901 Medrad Phased Array 1.5T Shoulder Imaging Surface CoilMedrad, Inc. · 1996
- This deviceK984257 Medrad Phased Array Neurovascular CoilMedrad, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK023596 Medrad 8-Receiver Phased Array Neurovascular CoilMedrad, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK093689 1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for SiemansMr Medical Solutions, LLC · 2010
- Descendant · 2 generations on · 0 of its ownK052827 Modification to Medrad 8-Receiver Phased Array Neurovascular Coil…Medrad, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- K023596Medrad 8-Receiver Phased Array Neurovascular CoilMedrad, Inc. · 2002 · cites it directly2descendants
- K0936891.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for SiemansMr Medical Solutions, LLC · 2010 · 2 generations on0descendants
- K052827Modification to Medrad 8-Receiver Phased Array Neurovascular Coil for SiemensMedrad, Inc. · 2005 · 2 generations on0descendants
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) | K984257 | Medrad Phased Array Neurovascular Coil | Medrad, Inc. | 1999 | — |
| +1 | K023596 | Medrad 8-Receiver Phased Array Neurovascular Coil | Medrad, Inc. | 2002 | — |
| +2 | K093689 | 1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for Siemans | Mr Medical Solutions, LLC | 2010 | — |
| +2 | K052827 | Modification to Medrad 8-Receiver Phased Array Neurovascular Coil for Siemens | Medrad, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K981094 | Medrad Neurovascular CoilSummary page 2…ce: The following table compares claims made in regard to the Medrad 1.5T Neurovascular Coil to the Medrad 1.5T Neurovascular Array Coll Medrad 1.5T NeurovascularCoil (K981094) Medrad Phased Array Shoulder Coil (K960901) Medrad 1.5T Neurovascular Array Coil Quadrature Transmit- Receive Coil Phased Ar… | 1998 |
| * | K960901 | Medrad Phased Array 1.5T Shoulder Imaging Surface CoilSummary page 2…in regard to the Medrad 1.5T Neurovascular Coil to the Medrad 1.5T Neurovascular Array Coll Medrad 1.5T NeurovascularCoil (K981094) Medrad Phased Array Shoulder Coil (K960901) Medrad 1.5T Neurovascular Array Coil Quadrature Transmit- Receive Coil Phased Array Receive-Only Coil Phased Array Receive-o… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023596 | Medrad 8-Receiver Phased Array Neurovascular Coil | 2002 | 2 |
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 4 ancestors has a recall.
- Of its descendants, K023596 (Medrad, Inc., 2002) has gone furthest, with 2 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 Phased Array Neurovascular Coil is a receive only, phased array coil designed to enhance the MR Imaging of the head and neck anatomy.
The Medrad Phased Array 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/K984257 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984257: Medrad Phased Array 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/K984257
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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