510(k) · Cleared
ClearedModification to Medrad 8-Receiver Phased Array Neurovascular Coil for Siemens
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 Nov 1, 2005 as substantially equivalent to K023596 (Medrad, Inc., 2002) after a 27-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Nov 1, 2005
- Review
- 27 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 deviceK052827 Modification to Medrad 8-Receiver Phased Array Neurovascular Coil…Medrad, Inc. · 2005
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) | 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 |
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 Coil Our reading of the summary gave K023569, FDA’s number for Siemens Multiview Workstation Modifications (Siemens Medical Solutions USA, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “MEDRAD 8-Receiver Phased Array Neurovascular Coil”. | 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 16 years and passes through 2 companies; a new generation was cleared every 3.8 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.
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 coil intended to be used with Siemens 1.5T MRI Scanners. The coil will facilitate complete MR imaging, including spectroscopy, of the intracranial/extracranial, neurovascular, skull base and C-spine regions without moving the patient or the coil; i.e., no scan room intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052827: Modification to Medrad 8-Receiver Phased Array Neurovascular Coil for Siemens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052827
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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