510(k) Report

510(k) · Cleared

Cleared

Mstar MPD4500

K073457510(k) TraditionalCleared Feb 1, 200853-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

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

Cleared on Feb 1, 2008 after a 53-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.

Decided
Feb 1, 2008
Review
53 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
0

10 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2009: 3 descendants cleared2013: 1 descendant cleared2010: 1 descendant cleared2012: 1 descendant cleared2011: 2 descendants cleared2021: 1 descendant cleared2023: 1 descendant cleared20052010201520202025
  1. This deviceK073457 Mstar MPD4500Xinaomdt Technology Co., Ltd. · 2008
  2. Descendant · cites it directly · 5 of its ownK091580 Pica Whole Body Mri SystemTime Medical Limited · 2009
  3. Descendant · 2 generations on · 2 of its ownK113281 Mri SytemsShenzhen Anke High-Tech Co., Ltd. · 2012
  4. Descendant · 3 generations on · 1 of its ownK202518 Promaxo MRI SystemPromaxo, Inc. · 2021
  5. Descendant · 2 generations on · 1 of its ownK093984 Pica Whole Body Mri System Model TMS-Mri-3500WB-01Time Medical Limited · 2010
  6. Descendant · cites it directly · 1 of its ownK092230 Mona - Orthopedic Mri System, Model TMS-200ORTH-01Time Medical Limited · 2009

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009: 32010: 12011: 22012: 12013: 12021: 12023: 1
2009high 3 (2009) · low 0 (2014)2026

Most influential descendants

Showing 5 of 10 · See all
  • K091580Pica Whole Body Mri SystemTime Medical Limited · 2009 · cites it directly5descendants
  • K113281Mri SytemsShenzhen Anke High-Tech Co., Ltd. · 2012 · 2 generations on2descendants
  • K202518Promaxo MRI SystemPromaxo, Inc. · 2021 · 3 generations on1descendant
  • K093984Pica Whole Body Mri System Model TMS-Mri-3500WB-01Time Medical Limited · 2010 · 2 generations on1descendant
  • K092230Mona - Orthopedic Mri System, Model TMS-200ORTH-01Time Medical Limited · 2009 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K073457Mstar MPD4500Xinaomdt Technology Co., Ltd.2008—
+1K091580Pica Whole Body Mri SystemTime Medical Limited2009—
+2K113281Mri SytemsShenzhen Anke High-Tech Co., Ltd.2012—
+3K202518Promaxo MRI SystemPromaxo, Inc.2021—
+2K093984Pica Whole Body Mri System Model TMS-Mri-3500WB-01Time Medical Limited2010—
+1K092230Mona - Orthopedic Mri System, Model TMS-200ORTH-01Time Medical Limited2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200930
201010
201120
201210
201310
202110
202310
FIG. 1 — Lineage of K073457, 2008–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K091580Pica Whole Body Mri SystemTime Medical Limited20095
K092230Mona - Orthopedic Mri System, Model TMS-200ORTH-01Time Medical Limited20091
K130658Elixbo PM545Xbo Medical Systems Co., Ltd.20130
K091669Open Magnetic Resonance Imaging System, Model MPF3000-IiiXioao Mdt Technology Co, Ltd.20090

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, K091580 (Time Medical Limited, 2009) has gone furthest, with 5 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. 2008, this device’s year, is highlighted.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

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

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
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

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

What is it indicated for?

mStar MPF4500 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 radiation. 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 (T2), and flow.

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in LNH

The LNH category page

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https://510kreport.com/device/K073457 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073457: Mstar MPD4500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073457

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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