510(k) · Cleared
ClearedTRILLIUM Oval Head Coil 32
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Sep 16, 2016 as substantially equivalent to K142734 (Hitachi Medical Systems America, Inc., 2015) after a 51-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Sep 16, 2016
- Review
- 51 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K955249 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK955249 Sensor PadInventive Products, Inc. · 1995
- 5 generations between
- 3 generations backK083533 Echelon C Mri SystemHitachi Medical Systems America, Inc. · 2009 · Recalled
- 2 generations backK113145 Echelon Oval Mri SystemHitachi Medical Systems America, Inc. · 2012 · Recalled
- 1 generation backK142734 TRILLIUM Oval MR SystemHitachi Medical Systems America, Inc. · 2015
- This deviceK162079 TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc. · 2016
Show all 9 generations
- Root · 9 generations backK955249 Sensor PadInventive Products, Inc. · 1995
- 8 generations backK973450 Sensor PadInventive Products, Inc. · 1997
- 7 generations backK991469 Aware PadAac Consulting Group, Inc. · 1999
- 6 generations backK023390 MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC · 2002
- 5 generations backK050602 AltaireHitachi Medical Systems America, Inc. · 2005
- 4 generations backK052172 HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · Recalled
- 3 generations backK083533 Echelon C Mri SystemHitachi Medical Systems America, Inc. · 2009 · Recalled
- 2 generations backK113145 Echelon Oval Mri SystemHitachi Medical Systems America, Inc. · 2012 · Recalled
- 1 generation backK142734 TRILLIUM Oval MR SystemHitachi Medical Systems America, Inc. · 2015
- This deviceK162079 TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K955249 | Sensor Pad | Inventive Products, Inc. | 1995 | — |
| −8 | K973450 | Sensor Pad | Inventive Products, Inc. | 1997 | — |
| −7 | K991469 | Aware Pad | Aac Consulting Group, Inc. | 1999 | — |
| −6 | K023390 | MY Breast Friend, Breast Self-Exam Pad | Mbf Sales, LLC | 2002 | — |
| −5 | K050602 | Altaire | Hitachi Medical Systems America, Inc. | 2005 | — |
| −4 | K052172 | HHF1 Magnetic Resonance Imaging System | Hitachi Medical Systems America, Inc. | 2005 | 3 |
| −3 | K083533 | Echelon C Mri System | Hitachi Medical Systems America, Inc. | 2009 | 2 |
| −2 | K113145 | Echelon Oval Mri System | Hitachi Medical Systems America, Inc. | 2012 | 3 |
| −1 | K142734 | TRILLIUM Oval MR System | Hitachi Medical Systems America, Inc. | 2015 | — |
| 0 (this device) | K162079 | TRILLIUM Oval Head Coil 32 | Hitachi Medical Systems America, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K142734 | TRILLIUM Oval MR SystemSummary page 5…UM OVAL Head Coil 32 Predicate Device(s): TRILLIUM OVAL WIT Posterior Head/Neck coil and WIT Anterior Head attachment (K142734) Device Intended Use The TRILLIUM OVAL Head Coil 32 is a 32 channel recieve-only multiple array device used with the Hitachi TRI… | 2015 |
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 4 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K142734.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 TRILLIUM OVAL Head Coil 32 is a 32 channel recieve-only multiple array device used with the Hitachi TRILLIUM OVAL 3.0 Tesla systems for imaging of the head region that can be interpreted by a trained physician.
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/K162079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162079: TRILLIUM Oval Head Coil 32.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162079
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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