510(k) · Cleared
ClearedHHF1 Echelon Multi-Purpose Coil
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 Aug 18, 2006 as substantially equivalent to K052172 (Hitachi Medical Systems America, Inc., 2005) after a 39-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Aug 18, 2006
- Review
- 39 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K955249 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK955249 Sensor PadInventive Products, Inc. · 1995
- 5 generations backK973450 Sensor PadInventive Products, Inc. · 1997
- 4 generations backK991469 Aware PadAac Consulting Group, Inc. · 1999
- 3 generations backK023390 MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC · 2002
- 2 generations backK050602 AltaireHitachi Medical Systems America, Inc. · 2005
- 1 generation backK052172 HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · Recalled
- This deviceK061950 HHF1 Echelon Multi-Purpose CoilHitachi Medical Systems America, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K955249 | Sensor Pad | Inventive Products, Inc. | 1995 | — |
| −5 | K973450 | Sensor Pad | Inventive Products, Inc. | 1997 | — |
| −4 | K991469 | Aware Pad | Aac Consulting Group, Inc. | 1999 | — |
| −3 | K023390 | MY Breast Friend, Breast Self-Exam Pad | Mbf Sales, LLC | 2002 | — |
| −2 | K050602 | Altaire | Hitachi Medical Systems America, Inc. | 2005 | — |
| −1 | K052172 | HHF1 Magnetic Resonance Imaging System | Hitachi Medical Systems America, Inc. | 2005 | 3 |
| 0 (this device) | K061950 | HHF1 Echelon Multi-Purpose Coil | Hitachi Medical Systems America, Inc. | 2006 | — |
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 |
|---|---|---|---|
| * | K052172 | HHF1 Magnetic Resonance Imaging SystemSummary page 4…chi Medical Systems America that the HHF1TM EchelonTM Multi- purpose Coil is substantially equivalent to the T/R Body coil cleared in HHFl Echelon MRI System (Cf K052172). The technological characteristics and intended use are identical to the Predicate Device. ©2006 Hitachi Medical Systems… | 2005 |
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 11 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 3 other devices also cite its predicate K052172.
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?
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the
musculoskeletal structures, soft tissue and vascular structures in various anatomic regions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061950 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061950: HHF1 Echelon Multi-Purpose Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061950
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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