# K051349: 3.0T Prostate Imaging System

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Jun 23, 2005 after 30 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: 2 generations back to K926571 (1993). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926571: Mrinnervu (R) Endorectal Prostate Coil BPX-15, Medrad, Inc. (1993) Summary page 1.
- K971380: Medrad Flex Interface Device, Medrad, Inc. (1997) Summary page 1.

## Most influential descendants
- K060401: Medrad 3.0T Ecoil Imaging System (2006), 1 descendant of its own
- K243428: e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector (2025), 0 descendants of its own
- K191539: 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support (2020), 0 descendants of its own
- K063342: Medrad Ecoil Imaging System for Philips (2006), 0 descendants of its own

## Indications for use
The 3.OT Prostate Imaging System 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 gland and surrounding pelvic tissue. The 3.OT Prostate Imaging System is intended for use with Siemens 3.OT Trio scanner platforms only. Only trained healthcare professionals are intended to operate this device.

Source page: https://510kreport.com/device/K051349
Methodology: https://510kreport.com/methodology