510(k) Report

510(k) · Cleared

Cleared

Mics Intervention Aid, Catalog # Mics-Mia and Mics-Mias

K020289510(k) TraditionalCleared Apr 24, 200286-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

Machnet BV · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Apr 24, 2002 as substantially equivalent to K000832 (Philips Medical Systems North America, Inc., 2000) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.

Decided
Apr 24, 2002
Review
86 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K000832 (2000). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2004: 1 descendant cleared2007: 1 descendant cleared2009: 1 descendant clearedK000832 · Sterotactic Localization Device (SLD) · Philips Medical Systems North America, Inc. · 2000200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants K000832 · Sterotactic Localization Device (SLD) · Philips Medical Systems North America, Inc. · 20000
  1. Root · 1 generation backK000832 Sterotactic Localization Device (SLD)Philips Medical Systems North America, Inc. · 2000
  2. This deviceK020289 Mics Intervention Aid, Catalog # Mics-Mia and Mics-MiasMachnet BV · 2002
  3. Descendant · cites it directly · 0 of its ownK090223 Icad Breast Interventional Planning Software, Model D70024Icad, Inc. · 2009 · Recalled
  4. Descendant · cites it directly · 0 of its ownK071534 Confirma Breast Mri Interventional ComponentsConfirma, Inc. · 2007
  5. Descendant · cites it directly · 0 of its ownK041020 Cadstream Version 3.1Confirma, Inc. · 2004

Most influential descendants

Showing 3 of 3 · See all
  • K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc. · 2009 · cites it directly0descendants
  • K071534Confirma Breast Mri Interventional ComponentsConfirma, Inc. · 2007 · cites it directly0descendants
  • K041020Cadstream Version 3.1Confirma, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000832Sterotactic Localization Device (SLD)Philips Medical Systems North America, Inc.2000—
0 (this device)K020289Mics Intervention Aid, Catalog # Mics-Mia and Mics-MiasMachnet BV2002—
+1K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.20091
+1K071534Confirma Breast Mri Interventional ComponentsConfirma, Inc.2007—
+1K041020Cadstream Version 3.1Confirma, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
200910
FIG. 1 — Lineage of K020289, 2000–2009Source: 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
*K000832Sterotactic Localization Device (SLD)
Summary page 1
…ice Equivalent legally marketed device: This device is similar in design and identical in function to the Philips Medical Systems Stereotactic Localization Device (SLD) K000832 and MRI Devices Corp Model MR-Biopsy 160, K010570, and Siemens Medical Systems MR Breast Biopsy Device KO10773 . Indications for…
Philips Medical Systems North America, Inc.2000—
*K010570Breast Immobiization and Biopsy Device MR-Biopsy 160
Summary page 1
…ce is similar in design and identical in function to the Philips Medical Systems Stereotactic Localization Device (SLD) K000832 and MRI Devices Corp Model MR-Biopsy 160, K010570, and Siemens Medical Systems MR Breast Biopsy Device KO10773 . Indications for Use (intended use):. For use in conjunction with…
Mri Devices Corp.2001—
*K010773Breast Biopsy Device/Magnetom Systems
Summary page 2
…tic Localization AID (MICS-MIA and Device (SLD) K000832 and MICS-MIAS MRI Devices Corp Model MR-Biopsy 160, K010570, and Siemens Medical Systems MR Breast Biopsy Device K010773 Indications for use For use in conjunction with | SAME a Magnetic Resonance Scanner to localize lesions in female breasts and per…
Siemens Medical Solutions USA, Inc.20011

Also cleared against K000832: 2 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.20090
K071534Confirma Breast Mri Interventional ComponentsConfirma, Inc.20070
K041020Cadstream Version 3.1Confirma, Inc.20040

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.
  • Of its descendants, K090223 (Icad, Inc., 2009) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K000832.

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?

The “MICS INTERVENTION AID (MICS-MIA and MICS-MIAS)” is for use in conjunction with a Magnetic Resonance Scanner and the Machnet Bilateral Open Breast Coil to localize lesions in female breasts and perform needle biopsies accurately. For use by a trained physician.

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

Also cleared against K000832

2 other devices cite the same predicate.

  • K041020Cadstream Version 3.1Confirma, Inc. · 2004
  • K023686Aurora MR-Guided Interventional SystemAurora Imaging Technology, Inc. · 2003

More from Machnet BV

3 FDA decisions under this applicant name. See the company

  • K013985Machnet Bilateral Open Breast Coil. Catalog # Mics-GSXXMachnet BV · 2002
  • K012491Machnet Carotids Coil Array AssemblyMachnet BV · 2001

Recent decisions in LNH

The LNH category page

  • K262902ECHELON SynergyFujifilm Corporation · 2026
  • K260092Vista AI ScanVista AI, Inc. · 2026
  • K261612SwiftSight-BodyCompositionAirs Medical, Inc. · 2026
  • K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026
  • K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd. · 2026

https://510kreport.com/device/K020289 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020289: Mics Intervention Aid, Catalog # Mics-Mia and Mics-Mias.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020289

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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