# K974438: Medrad Atd-T Interface Device

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Apr 30, 1998 after 157 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
No predicates in its family tree.
220 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) GE 1.5T Atd-II: named in the summary without a submission number

## Most influential descendants
- K053042: Medrad 1.5T Pelvic Imaging System Interface Device (2005), 219 descendants of its own
- 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

## Indications for use
The purpose of the ATD-T is to provide interface and support functions to allow the use of Medrad disposable endorectal coils with the GEMS Signa 1.5 Tesla MRI Scanner System and Torso Array Coil. The use of the ATD-T is a requirement whenever MR imaging is to be performed using the GEMS Signa 1.5 Tesla MRI System with the Torso Array Coil and any of the Medrad family of disposable endorectal coils. Use of the ATD-T is indicated with all 1.5 Tesla Endorectal Coils.

Source page: https://510kreport.com/device/K974438
Methodology: https://510kreport.com/methodology