510(k) · Cleared

Cleared

Medrad Flex Interface Device

K971380510(k) TraditionalCleared Jul 3, 199780-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medrad, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jul 3, 1997 as substantially equivalent to K926571 (Medrad, Inc., 1993) after an 80-day review. Its family tree reaches back 1 generation to 1993. 5 later devices descend from it.

Decided: Jul 3, 1997
Review: 80 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K926571 (1993). 5 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK926571 Mrinnervu (R) Endorectal Prostate Coil BPX-15Medrad, Inc. · 1993
This deviceK971380 Medrad Flex Interface DeviceMedrad, Inc. · 1997
Descendant · cites it directly · 4 of its ownK051349 3.0T Prostate Imaging SystemMedrad, Inc. · 2005
Descendant · 2 generations on · 1 of its ownK060401 Medrad 3.0T Ecoil Imaging SystemMedrad, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK243428 e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems…Dxtx Medical, Inc. · 2025
Descendant · 3 generations on · 0 of its ownK191539 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH · 2020
Descendant · 2 generations on · 0 of its ownK063342 Medrad Ecoil Imaging System for PhilipsMedrad, Inc. · 2006

Most influential descendants

Showing 5 of 5 · See all

K0513493.0T Prostate Imaging SystemMedrad, Inc. · 2005 · cites it directly4descendants
K060401Medrad 3.0T Ecoil Imaging SystemMedrad, Inc. · 2006 · 2 generations on1descendant
K243428e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G ConnectorDxtx Medical, Inc. · 2025 · 2 generations on0descendants
K1915391.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH · 2020 · 3 generations on0descendants
K063342Medrad Ecoil Imaging System for PhilipsMedrad, Inc. · 2006 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K926571	Mrinnervu (R) Endorectal Prostate Coil BPX-15	Medrad, Inc.	1993	—
0 (this device)	K971380	Medrad Flex Interface Device	Medrad, Inc.	1997	—
+1	K051349	3.0T Prostate Imaging System	Medrad, Inc.	2005	—
+2	K060401	Medrad 3.0T Ecoil Imaging System	Medrad, Inc.	2006	—
+2	K243428	e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G…	Dxtx Medical, Inc.	2025	—
+3	K191539	1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support	Rapid Biomedical GmbH	2020	—
+2	K063342	Medrad Ecoil Imaging System for Philips	Medrad, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2020	1	0
2025	1	0

FIG. 1 — Lineage of K971380, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LNH device

#1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K926571	Mrinnervu (R) Endorectal Prostate Coil BPX-15 Summary page 1 …sory[21 CFR 892.1000} COMMON/USUAL NAME: Interface Device(Connector) PROPRIETARY NAME: Medrad Flex Interface Device PREDICATE DEVICES: Medrad Probe Interface Device - K926571 DEVICE DESCRIPTION: The Medrad Magnetic Resonance Endorectal Coil Imaging System consists of a disposable, receive only probe f…	Medrad, Inc.	1993	—

Also cleared against K926571: 1 other device →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051349	3.0T Prostate Imaging System	Medrad, Inc.	2005	4

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K051349 (Medrad, Inc., 2005) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K926571.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	12	35	25	114
2008	19	53	12	167
2009	17	70	7	194
2010	12	94	17	165
2011	16	81	11	182
2012	22	89	5	170
2013	19	108	2	107
2014	17	108	13	119
2015	19	140	12 (2)	113
2016	20	108	1	135
2017	18	98	0	121
2018	29	128	71	158
2019	26	62	5	158
2020	32	121	4	98
2021	27	87	41	84
2022	30	74	13	138
2023	30	124	10 (1)	159
2024	26	104	4	281
2025	26	122	8 (5)	1,263
2026	24	126	43	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971380 · printed Nov 5, 2026

Cite this page

510(k) Report. “K971380: Medrad Flex Interface Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971380

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026