# K243428: e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector

- Pathway: 510(k) (Abbreviated)
- Applicant: Dxtx Medical, Inc.
- Decided: Jul 17, 2025 after 254 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K926571 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051349: 3.0T Prostate Imaging System, Medrad, Inc. (2005) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K243428
Methodology: https://510kreport.com/methodology