# K053042: Medrad 1.5T Pelvic Imaging System Interface Device

- Pathway: 510(k) (Special)
- Applicant: Medrad, Inc.
- Decided: Nov 17, 2005 after 20 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: 1 generation back to K974438 (1998). 1 ancestor in all.
219 later devices descend from it; 3 cite it directly.
19 of 221 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974438: Medrad Atd-T Interface Device, Medrad, Inc. (1998) Summary page 1.

## Most influential descendants
- K103274: Sentinelle Endo Coil Array for Pelvic Imaging (2011), 216 descendants of its own
- 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

## Indications for use
The 1.5T Pelvic 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 colon, cervix or prostate and surrounding pelvic tissue. The purpose of the interface device for the Pelvic Imaging System is to provide interface and support functions to allow the use of MEDRAD 1.5T disposable endorectal coils with GE Signa EXCITE 1.5T MRI scanner systems and body array coils. Only trained healthcare professionals are intended to operate this device.

Source page: https://510kreport.com/device/K053042
Methodology: https://510kreport.com/methodology