510(k) · Cleared
ClearedBreast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA and BI 160-CC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noras Rontgen-Und Medizintechnik GmbH · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Nov 8, 2005 as substantially equivalent to K010570 (Mri Devices Corp., 2001) after a 15-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Nov 8, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010570 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010570 Breast Immobiization and Biopsy Device MR-Biopsy 160Mri Devices Corp. · 2001
- This deviceK052987 Breast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA…Noras Rontgen-Und Medizintechnik GmbH · 2005
- Descendant · cites it directly · 0 of its ownK081118 Noras MR-BI320-PA 1.5TNoras Mri Products GmbH · 2008
- Descendant · cites it directly · 0 of its ownK071534 Confirma Breast Mri Interventional ComponentsConfirma, Inc. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010570 | Breast Immobiization and Biopsy Device MR-Biopsy 160 | Mri Devices Corp. | 2001 | — |
| 0 (this device) | K052987 | Breast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA and BI… | Noras Rontgen-Und Medizintechnik GmbH | 2005 | — |
| +1 | K081118 | Noras MR-BI320-PA 1.5T | Noras Mri Products GmbH | 2008 | — |
| +1 | K071534 | Confirma Breast Mri Interventional Components | Confirma, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K010570 | Breast Immobiization and Biopsy Device MR-Biopsy 160Summary page 1…resonance NAME imaging REGULATION NUMBER 892.1000 510(K) NUMBER K010570 BREAST IMMOBIIZATION AND DEVICE NAME BIOPSY DEV… | 2001 |
What descends from it? (2)
2 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?
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 | — |
What is it indicated for?
The Breast Immobilization and Biopsy Device Models BI 160-0, BI 160-PA, and BI 160-CC are used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and wire localization of lesions that can be performed and interpreted by a trained physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052987 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052987: Breast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA and BI 160-CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052987
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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