510(k) · Cleared

Cleared

MR Guided Procedures Package/Magnetom Open System

K955389510(k) TraditionalCleared Jun 10, 1996199-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

Siemens Medical Solutions USA, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jun 10, 1996 after a 199-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.

Decided: Jun 10, 1996
Review: 199 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 0

7 later devices descend from it, 2 citing it directly.

This deviceK955389 MR Guided Procedures Package/Magnetom Open SystemSiemens Medical Solutions USA, Inc. · 1996
Descendant · cites it directly · 4 of its ownK983342 MR Guided Procedures (MRGP) Basic PackagePhilips Medical Systems (Cleveland), Inc. · 1998
Descendant · 2 generations on · 2 of its ownK022007 Liberty 5000 Breast Coil with Disposable Biopsy PlatesUsa Instruments, Inc. · 2002
Descendant · cites it directly · 1 of its ownK984280 Airis II Magnetic Resonance Diagnostic Device,Interventional MR…Hitachi Medical Systems America, Inc. · 1999
Descendant · 2 generations on · 0 of its ownK053309 Altaire Interventional MR PackageHitachi Medical Systems America, Inc. · 2006
Descendant · 3 generations on · 0 of its ownK050728 Open Breast Coil (Obc) with Biopsy PlatesUsa Instruments, Inc. · 2005

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1998high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 7 · See all

K983342MR Guided Procedures (MRGP) Basic PackagePhilips Medical Systems (Cleveland), Inc. · 1998 · cites it directly4descendants
K022007Liberty 5000 Breast Coil with Disposable Biopsy PlatesUsa Instruments, Inc. · 2002 · 2 generations on2descendants
K984280Airis II Magnetic Resonance Diagnostic Device,Interventional MR PackageHitachi Medical Systems America, Inc. · 1999 · cites it directly1descendant
K053309Altaire Interventional MR PackageHitachi Medical Systems America, Inc. · 2006 · 2 generations on0descendants
K050728Open Breast Coil (Obc) with Biopsy PlatesUsa Instruments, Inc. · 2005 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K955389	MR Guided Procedures Package/Magnetom Open System	Siemens Medical Solutions USA, Inc.	1996	—
+1	K983342	MR Guided Procedures (MRGP) Basic Package	Philips Medical Systems (Cleveland), Inc.	1998	—
+2	K022007	Liberty 5000 Breast Coil with Disposable Biopsy Plates	Usa Instruments, Inc.	2002	—
+1	K984280	Airis II Magnetic Resonance Diagnostic Device,Interventional MR Package	Hitachi Medical Systems America, Inc.	1999	—
+2	K053309	Altaire Interventional MR Package	Hitachi Medical Systems America, Inc.	2006	—
+3	K050728	Open Breast Coil (Obc) with Biopsy Plates	Usa Instruments, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2002	1	0
2003	1	0
2005	1	0
2006	1	0

FIG. 1 — Lineage of K955389, 1996–2006Source: 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
*	—	Magnetom Open Named without a submission number			—

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K983342	MR Guided Procedures (MRGP) Basic Package	Philips Medical Systems (Cleveland), Inc.	1998	4
K984280	Airis II Magnetic Resonance Diagnostic Device,Interventional MR Package	Hitachi Medical Systems America, Inc.	1999	1

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?

Of its descendants, K983342 (Philips Medical Systems (Cleveland), Inc., 1998) has gone furthest, with 4 descendants of its own.

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 MR-guided procedure package is designed to support diagnostic, interventional needle biopsies and drainages.

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/K955389 · printed Nov 5, 2026

Cite this page

510(k) Report. “K955389: MR Guided Procedures Package/Magnetom Open System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955389

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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