510(k) · Cleared
ClearedSterotactic Localization Device (SLD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Apr 27, 2000 after a 44-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 27, 2000
- Review
- 44 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK000832 Sterotactic Localization Device (SLD)Philips Medical Systems North America, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK020289 Mics Intervention Aid, Catalog # Mics-Mia and Mics-MiasMachnet BV · 2002
- Descendant · 2 generations on · 0 of its ownK090223 Icad Breast Interventional Planning Software, Model D70024Icad, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK071534 Confirma Breast Mri Interventional ComponentsConfirma, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK041020 Cadstream Version 3.1Confirma, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK023686 Aurora MR-Guided Interventional SystemAurora Imaging Technology, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K020289Mics Intervention Aid, Catalog # Mics-Mia and Mics-MiasMachnet BV · 2002 · cites it directly3descendants
- K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc. · 2009 · 2 generations on0descendants
- K071534Confirma Breast Mri Interventional ComponentsConfirma, Inc. · 2007 · 2 generations on0descendants
- K041020Cadstream Version 3.1Confirma, Inc. · 2004 · cites it directly0descendants
- K023686Aurora MR-Guided Interventional SystemAurora Imaging Technology, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000832 | Sterotactic Localization Device (SLD) | Philips Medical Systems North America, Inc. | 2000 | — |
| +1 | K020289 | Mics Intervention Aid, Catalog # Mics-Mia and Mics-Mias | Machnet BV | 2002 | — |
| +2 | K090223 | Icad Breast Interventional Planning Software, Model D70024 | Icad, Inc. | 2009 | 1 |
| +2 | K071534 | Confirma Breast Mri Interventional Components | Confirma, Inc. | 2007 | — |
| +1 | K041020 | Cadstream Version 3.1 | Confirma, Inc. | 2004 | — |
| +1 | K023686 | Aurora MR-Guided Interventional System | Aurora Imaging Technology, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K020289 (Machnet BV, 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 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 | — |
https://510kreport.com/device/K000832 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000832: Sterotactic Localization Device (SLD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000832
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026