510(k) · Cleared
ClearedHRH-63-8 Head Array Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mri Devices Corp. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Oct 16, 2001 after a 25-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.
- Decided
- Oct 16, 2001
- Review
- 25 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 4 citing it directly.
- This deviceK013159 HRH-63-8 Head Array CoilMri Devices Corp. · 2001
- Descendant · cites it directly · 5 of its ownK022669 8 Channel Cardiac Phased Array CoilGE Medical Systems · 2002
- Descendant · cites it directly · 4 of its ownK060758 OR Head Coil 1.5 TSiemens Medical Solutions USA, Inc. · 2006
- Descendant · 2 generations on · 3 of its ownK031209 GE 1.5T 8 Channel Torso CoilGe Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK110411 Atama SystemMonteris Medical, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK091546 Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230Noras Mri Products GmbH · 2009
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K0226698 Channel Cardiac Phased Array CoilGE Medical Systems · 2002 · cites it directly5descendants
- K060758OR Head Coil 1.5 TSiemens Medical Solutions USA, Inc. · 2006 · cites it directly4descendants
- K031209GE 1.5T 8 Channel Torso CoilGe Medical Systems, Inc. · 2003 · 2 generations on3descendants
- K110411Atama SystemMonteris Medical, Inc. · 2011 · 2 generations on1descendant
- K091546Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230Noras Mri Products GmbH · 2009 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013159 | HRH-63-8 Head Array Coil | Mri Devices Corp. | 2001 | — |
| +1 | K022669 | 8 Channel Cardiac Phased Array Coil | GE Medical Systems | 2002 | — |
| +1 | K060758 | OR Head Coil 1.5 T | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +2 | K031209 | GE 1.5T 8 Channel Torso Coil | Ge Medical Systems, Inc. | 2003 | — |
| +2 | K110411 | Atama System | Monteris Medical, Inc. | 2011 | — |
| +1 | K091546 | Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230 | Noras Mri Products GmbH | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K022669 (GE Medical Systems, 2002) has gone furthest, with 5 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?
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head, that can be interpreted by a trained physician.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013159: HRH-63-8 Head Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013159
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026