510(k) · Cleared
ClearedNoras MR-BI320-PA 1.5T
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 May 2, 2008 as substantially equivalent to K002602 (Mri Devices Corp., 2000) and 2 other predicates after an 11-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- May 2, 2008
- Review
- 11 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K010570 (2001). 3 ancestors in all, the oldest K002602 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK010570 Breast Immobiization and Biopsy Device MR-Biopsy 160Mri Devices Corp. · 2001
- 1 generation backK052987 Breast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA…Noras Rontgen-Und Medizintechnik GmbH · 2005
- This deviceK081118 Noras MR-BI320-PA 1.5TNoras Mri Products GmbH · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010570 | Breast Immobiization and Biopsy Device MR-Biopsy 160 | Mri Devices Corp. | 2001 | — |
| −1 | K052987 | Breast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA and BI… | Noras Rontgen-Und Medizintechnik GmbH | 2005 | — |
| 0 (this device) | K081118 | Noras MR-BI320-PA 1.5T | Noras Mri Products GmbH | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002602 | Obc-63 Mebreast Array CoilSummary page 4…Coil Name Premarket Notification Clearance Date MRI Devices Corporation (Now Known as Invivo K002602 September 08, 2000 Corporation) Breast Array Coil Mode… | 2000 |
| * | K010570 | Breast Immobiization and Biopsy Device MR-Biopsy 160Summary page 4…M.:~i:.!~o s Pe Notification Clearance Datel Noras Imobilization and Biopsy Unit ~K010570 April 09, 2001 Model BI 160 Noras Immobilization and Bi… | 2001 |
| * | K052987 | Breast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA and BI 160-CCSummary page 4…~K010570 April 09, 2001 Model BI 160 Noras Immobilization and Biopsy Unit K052987 November 08,2005 Model B1160-PA Noras 510(k) Premarket Notification April 04, 2008… | 2005 |
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 the Noras MR-BI320-PA 1.5T 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 physician, these images provide information that can be useful in determining diagnosis.
The included Breast Biopsy Unit BI160-2 permits MR guided breast biopsy, wire localization of lesions that can be performed by a trained physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081118: Noras MR-BI320-PA 1.5T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081118
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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