# K971380: Medrad Flex Interface Device

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Jul 3, 1997 after 80 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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 K926571 (1993). 1 ancestor in all.
5 later devices descend from it; 1 cites 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.

## Most influential descendants
- K051349: 3.0T Prostate Imaging System (2005), 4 descendants of its own
- 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 Medrad Flex Interface Device(FID) provides the interface, connection, and support functions to permit the use of Medrad Disposable Endorectal Prostate, Cervix, and Colon Coils, with the Siemens Medical Systems Vision 1.5 Tesla and Impact 1.0 Tesla MRI Scanner Systems. The Medrad Flex Interface Device and the the Medrad Disposable Endorectal Prostate(BPX), Cervix(BCR), and Colon(PCC) Coils are intended for high resolution Magnetic Resonance Imaging of the human prostate, cervix, colon, and the surrounding pelvic anatomy.

Source page: https://510kreport.com/device/K971380
Methodology: https://510kreport.com/methodology