510(k) · Cleared

Cleared

Open Magnetic Resonance Imaging System, Model MPF3000-Iii

K091669510(k) TraditionalCleared Jun 18, 20099-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

Xioao Mdt Technology Co, Ltd. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jun 18, 2009 as substantially equivalent to K073457 (Xinaomdt Technology Co., Ltd., 2008) after a 9-day review. Its family tree reaches back 1 generation to 2008.

Decided: Jun 18, 2009
Review: 9 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K073457 (2008). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK073457 Mstar MPD4500Xinaomdt Technology Co., Ltd. · 2008
This deviceK091669 Open Magnetic Resonance Imaging System, Model MPF3000-IiiXioao Mdt Technology Co, Ltd. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K073457	Mstar MPD4500	Xinaomdt Technology Co., Ltd.	2008	—
0 (this device)	K091669	Open Magnetic Resonance Imaging System, Model MPF3000-Iii	Xioao Mdt Technology Co, Ltd.	2009	—

FIG. 1 — Lineage of K091669, 2008–2009Source: 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
*	K073457	Mstar MPD4500 Summary page 1 …, MPF3000-III Common Name: System, Nuclear Magnetic Resonance Imaging Classification: Class II, LNH, 892.1000 Predicate Device: mStar MPF4500 (K073457) Intended Use: Open Magnetic Resonance Imaging System, MPF3000-III is an imaging device, and is…	Xinaomdt Technology Co., Ltd.	2008	—

Also cleared against K073457: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
3 other devices also cite its predicate K073457.

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. 2009, this device’s year, is highlighted.

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?

Open Magnetic Resonance Imaging System, MPF3000-111 is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiationr. The MR system produces transverse, coronal, sagittal and oblique images that display the internal structure of the head, body or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (E)and flow.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091669 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091669: Open Magnetic Resonance Imaging System, Model MPF3000-Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091669

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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