510(k) · Cleared
ClearedBreast BI 7 MR Coil 1.5T Mammavention
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noras Mri Products GmbH · MOS Coil, Magnetic Resonance, Specialty
Cleared on Feb 16, 2018 as substantially equivalent to K162651 (Moras Mri Products GmbH, 2017) after a 31-day review. Its family tree reaches back 2 generations to 2008. 1 later device descends from it.
- Decided
- Feb 16, 2018
- Review
- 31 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K082373 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK082373 Noras MR-BI320-PA 3TNoras Mri Products GmbH · 2008
- 1 generation backK162651 Breast BI 7 MR Coil Mammavention 3TMoras Mri Products GmbH · 2017
- This deviceK180123 Breast BI 7 MR Coil 1.5T MammaventionNoras Mri Products GmbH · 2018
- Descendant · cites it directly · 0 of its ownK220144 Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7…Noras Mri Products GmbH · 2022
Most influential descendants
Showing 1 of 1 · See all- K220144Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3TNoras Mri Products GmbH · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082373 | Noras MR-BI320-PA 3T | Noras Mri Products GmbH | 2008 | — |
| −1 | K162651 | Breast BI 7 MR Coil Mammavention 3T | Moras Mri Products GmbH | 2017 | — |
| 0 (this device) | K180123 | Breast BI 7 MR Coil 1.5T Mammavention | Noras Mri Products GmbH | 2018 | — |
| +1 | K220144 | Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil… | Noras Mri Products GmbH | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 MOS? 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 MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 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 |
|---|---|---|---|
| * | K162651 | Breast BI 7 MR Coil Mammavention 3TSummary page 7…ing multipurpose coil: Predicate Device Name 510(k) Clearance Comparable and Number Date Froduet Corde Properties Manufacturer Proton imaging Breast Bl 7 MR " . Coil 3T K162651 January 18 90MOS High resolutlon.of ; 2017 breast anatomic Mammavention : regions T Summary of Technological Characteristics of t… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220144 | Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T | 2022 | 0 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K220144 (Noras Mri Products GmbH, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K162651.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, 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 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The intended use of Breast BI 7 MR Coil 1.5T Mammavention is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physican, these images provide information that can be useful in determining diagnosis. The included Breast…
Read the full statement (116 words)
The intended use of Breast BI 7 MR Coil 1.5T Mammavention is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physican, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and wire localization of lesions chan be performed by a trained physician.
The coil system Breast BI 7 MR Coil Mammavention 1.5T can be used with the following MRI systems:
1.5T: Siemens 1.5T: Avanto fit, Aera, Amira
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180123 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180123: Breast BI 7 MR Coil 1.5T Mammavention.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180123
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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