510(k) · Cleared
Clearede2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dxtx Medical, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jul 17, 2025 as substantially equivalent to K051349 (Medrad, Inc., 2005) after a 254-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Jul 17, 2025
- Review
- 254 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K926571 (1993). No later device cites it as a predicate yet.
- 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 deviceK243428 e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems…Dxtx Medical, Inc. · 2025
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) | K243428 | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G… | Dxtx Medical, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K051349 | 3.0T Prostate Imaging SystemSummary page 5…0 Product Code: MOS Regulatory class: II Review Panel: Radiology III. Predicate Device 510(k): K051349 Trade name: 3.0T Prostate Imaging System Common Name: Prostate Endo Coil Classificati… | 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 32 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K051349.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Probe: The DxTx e2Coil probes are recommended for high-resolution magnetic resonance imaging, including spectroscopy, of the prostate and surrounding pelvic tissue in the male human anatomies and are specifically designed for use with the appropriate e2Coil Interface Device and Intermediate Cable Assembly. The one-time use, disposable e2Coil probe has been designed to be inserted into the human rectum. The e2Coil probe may be inserted by a trained…
Read the full statement (129 words)
Probe: The DxTx e2Coil probes are recommended for high-resolution magnetic resonance imaging, including spectroscopy, of the prostate and surrounding pelvic tissue in the male human anatomies and are specifically designed for use with the appropriate e2Coil Interface Device and Intermediate Cable Assembly. The one-time use, disposable e2Coil probe has been designed to be inserted into the human rectum. The e2Coil probe may be inserted by a trained healthcare professional, depending on state or country law, who has training in e2Coil probe insertion.
Interface Device: The Siemens 3.0T Endo Interface II with Tim 4G SlideConnect (e2CoilTM) provides interface and support functions to allow the use of 3.0T disposable e2Coil probes with Siemens 3.0T MRI Systems with a Tim 4G connector. Only trained healthcare professionals are intended to operate this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243428 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243428: e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243428
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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