510(k) · Cleared
Cleared1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for Siemans
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mr Medical Solutions, LLC · MOS Coil, Magnetic Resonance, Specialty
Cleared on Aug 31, 2010 as substantially equivalent to K023596 (Medrad, Inc., 2002) after a 274-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Aug 31, 2010
- Review
- 274 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K892235 (1989). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK892235 GE Shoulder Surface Coil, Cat. #M1085ANGeneral Electric Co. · 1989
- 3 generations backK960901 Medrad Phased Array 1.5T Shoulder Imaging Surface CoilMedrad, Inc. · 1996
- 2 generations backK984257 Medrad Phased Array Neurovascular CoilMedrad, Inc. · 1999
- 1 generation backK023596 Medrad 8-Receiver Phased Array Neurovascular CoilMedrad, Inc. · 2002
- This deviceK093689 1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for SiemansMr Medical Solutions, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K892235 | GE Shoulder Surface Coil, Cat. #M1085AN | General Electric Co. | 1989 | — |
| −3 | K960901 | Medrad Phased Array 1.5T Shoulder Imaging Surface Coil | Medrad, Inc. | 1996 | — |
| −2 | K984257 | Medrad Phased Array Neurovascular Coil | Medrad, Inc. | 1999 | — |
| −1 | K023596 | Medrad 8-Receiver Phased Array Neurovascular Coil | Medrad, Inc. | 2002 | — |
| 0 (this device) | K093689 | 1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for Siemans | Mr Medical Solutions, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 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? (1)
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 |
|---|---|---|---|
| * | K023596 | Medrad 8-Receiver Phased Array Neurovascular CoilSummary page 1…ng Surface Coil Classification Number: 21 CFR 892.1000 Predicate Device: 1.5 Tesla 8-Receiver Neurovascular Coil, 510(k) number K023596 Substantial Equivalence: The information provided in this premarket notification demonstrates that the proposed d… | 2002 |
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 21 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K023596.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a
receive-only coil intended to be used with 1.5T Siemens superconducting MRI scanners. The
coil is intended to facilitate complete MR imaging of the intracranial/extracranial
neurovasculature and skull base.
The MR Medical Solutions 1.5 Tesla 16-Channel Receive-only Phased-array Head Coil is a
receive-only coil and is indicated for use only under the supervision of a physician or certified
MR technologist who is trained in the field of Diagnostic Magnetic Resonance Imaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093689: 1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for Siemans.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093689
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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