510(k) Report

510(k) · Cleared

Cleared

Virgo Mri System

K990153510(k) TraditionalCleared Oct 8, 1999262-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

Millennium Technology Services · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Oct 8, 1999 as substantially equivalent to K961876 (Hitachi Medical Systems America, Inc., 1996) and 2 other predicates after a 262-day review. Its family tree reaches back 1 generation to 1996.

Decided
Oct 8, 1999
Review
262 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K961876 (1996). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 2 other ancestorsK961876 · AIRIS · Hitachi Medical Systems America, Inc. · 1996199619982000
Other ancestors, by generation 1 generation back: 2 other ancestors K961876 · AIRIS · Hitachi Medical Systems America, Inc. · 19960
  1. Root · 1 generation backK961876 AIRISHitachi Medical Systems America, Inc. · 1996
  2. This deviceK990153 Virgo Mri SystemMillennium Technology Services · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K961876AIRISHitachi Medical Systems America, Inc.1996—
0 (this device)K990153Virgo Mri SystemMillennium Technology Services1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820
FIG. 1 — Lineage of K990153, 1996–1999Source: 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 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. #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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K961876AIRIS
Summary page 2
…ivalent Predicate Device: MILLENNIUM TECHNOLOGY, INC. believes that the Vg™ MRI SYSTEM is substantially equivalent to the following MRI system: 1. AIRIS I M.R.I System, K961876, K974212, K980691 by Hitachi Medical Systems America. The comparison device represents an MRI system that is functionally and te…
Hitachi Medical Systems America, Inc.1996—
*K974212Airis II
Summary page 2
…redicate Device: MILLENNIUM TECHNOLOGY, INC. believes that the Vg™ MRI SYSTEM is substantially equivalent to the following MRI system: 1. AIRIS I M.R.I System, K961876, K974212, K980691 by Hitachi Medical Systems America. The comparison device represents an MRI system that is functionally and technologic…
Hitachi Medical Systems America, Inc.19985
*K980691Airis Magnetic Resonance Diagnostic Device
Summary page 2
…Device: MILLENNIUM TECHNOLOGY, INC. believes that the Vg™ MRI SYSTEM is substantially equivalent to the following MRI system: 1. AIRIS I M.R.I System, K961876, K974212, K980691 by Hitachi Medical Systems America. The comparison device represents an MRI system that is functionally and technologically equi…
Hitachi Medical Systems America, Inc.1998—

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?

  • 1 of the 3 ancestors has a recall of any class.

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

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?

Non-invasive, non-ionizing diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities.

Diagnostic Image capabilities include:

Sagittal section images

Cross section & curved cross section images

Transverse section images

Coronal section images

2D Fast Spin Echo

2D Inversion Recovery

2D Fast Inversion Recovery

2D Dual Slice Acquisition

2D/3D Spin Echo

2D/3D Gradient Echo

2D/3D Gradient Echo w/ Rephasing

2D/3D Steady State Acquisition w/ rewind Gradient Echo (SARGE)

MR Angiography Image Processing

MR Angiography - Half Echo/High Resolution High Definition

2D/T1/T2 Weighted Imaging

T1/T2 Proton Density Measurements

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

Recent decisions in LNH

The LNH category page

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  • K261612SwiftSight-BodyCompositionAirs Medical, Inc. · 2026
  • K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026
  • K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd. · 2026

https://510kreport.com/device/K990153 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990153: Virgo Mri System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990153

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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