# K103274: Sentinelle Endo Coil Array for Pelvic Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Sentinelle Medical, Inc.
- Decided: Aug 18, 2011 after 286 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 K974438 (1998). 2 ancestors in all.
216 later devices descend from it; 1 cites it directly.
19 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053042: Medrad 1.5T Pelvic Imaging System Interface Device, Medrad, Inc. (2005) Summary page 1.

## Most influential descendants
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio (2012), 215 descendants of its own
- K141977: Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel (2014), 115 descendants of its own
- K151579: MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit (2015), 85 descendants of its own
- K153343: MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit (2016), 84 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own

## Indications for use
The Sentinelle Endo Coil Array is a receive-only MRI coil array which must be used by a qualified medical professional to obtain images of (including spectroscopy images) the prostate, cervix and colon and the surrounding tissues in the pelvis. The Coil Array is a reusable transrectal or transvaginal device that can be high level disinfected. This product is for exclusive use on adult populations with clinically present anus and rectum or vagina. For use with GE, Toshiba and Siemens 1.5T MR systems.

Source page: https://510kreport.com/device/K103274
Methodology: https://510kreport.com/methodology