510(k) · Cleared
ClearedMedrad 3.0T Ecoil Imaging System
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 Mar 15, 2006 as substantially equivalent to K053042 (Medrad, Inc., 2005) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Mar 15, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K926571 (1993). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK926571 Mrinnervu (R) Endorectal Prostate Coil BPX-15Medrad, Inc. · 1993
- 2 generations backK971380 Medrad Flex Interface DeviceMedrad, Inc. · 1997
- 1 generation backK051349 3.0T Prostate Imaging SystemMedrad, Inc. · 2005
- This deviceK060401 Medrad 3.0T Ecoil Imaging SystemMedrad, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK191539 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH · 2020
Most influential descendants
Showing 1 of 1 · See all- K1915391.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926571 | Mrinnervu (R) Endorectal Prostate Coil BPX-15 | Medrad, Inc. | 1993 | — |
| −2 | K971380 | Medrad Flex Interface Device | Medrad, Inc. | 1997 | — |
| −1 | K051349 | 3.0T Prostate Imaging System | Medrad, Inc. | 2005 | — |
| 0 (this device) | K060401 | Medrad 3.0T Ecoil Imaging System | Medrad, Inc. | 2006 | — |
| +1 | K191539 | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support | Rapid Biomedical GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K053042 | Medrad 1.5T Pelvic Imaging System Interface DeviceSummary page 1…MEDRAD 3.OT eCoil Imaging System PREDICATE DEVICES: MEDRAD, INC. 1.5T Pelvic Imaging System Interface Device (K053042) MEDRAD, INC. 3.OT Prostate Imaging System (KO51349) IN… | 2005 |
| * | K051349 | 3.0T Prostate Imaging System | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191539 | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support | 2020 | 0 |
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 13 years and passes through 1 company; a new generation was cleared every 4.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K191539 (Rapid Biomedical GmbH, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K053042.
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 eCoil Imaging System for the GE 3.01 family of scanners is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human prostate and surrounding pelvic tissue. The purpose of the interface device for the eCoil Imaging System is to provide interface and support functions to allow the use of MEDRAD 3.01 disposable endorectal coils with GE 3.0T family of scanner systems and Torso Array coils. Only trained healthcare professionals are intended to operate this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060401: Medrad 3.0T Ecoil Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060401
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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