510(k) · Cleared
ClearedDS Breast 16CH I/T 1.5T DS Breast 16CH I/T 3.0T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Corporation · MOS Coil, Magnetic Resonance, Specialty
Cleared on Nov 2, 2012 as substantially equivalent to K032576 (Mri Devices Corp., 2003) and 1 other predicate after a 64-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Nov 2, 2012
- Review
- 64 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K032576 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK032576 Biopsy Breast Coil, Model BBCMri Devices Corp. · 2003 · Recalled
- This deviceK122646 DS Breast 16CH I/T 1.5T DS Breast 16CH I/T 3.0TInvivo Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032576 | Biopsy Breast Coil, Model BBC | Mri Devices Corp. | 2003 | 4 |
| 0 (this device) | K122646 | DS Breast 16CH I/T 1.5T DS Breast 16CH I/T 3.0T | Invivo Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (2)
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 |
|---|---|---|---|
| * | K032576 | Biopsy Breast Coil, Model BBCSummary page 1…coil receives radio frequency signals from the tissue of interest. Substantial Equivalence Information: When compared to the predicate Breast Biopsy Coil (BBC) devices (K032576 and K041481), substantial equivalence of the dS Breast l6ch (1.5 T & 3.1T) devices is based on similarities in intended use, desi… | 2003 |
| * | K041481 | Model BBC-127 Biopsy Breast CoilSummary page 1…s radio frequency signals from the tissue of interest. Substantial Equivalence Information: When compared to the predicate Breast Biopsy Coil (BBC) devices (K032576 and K041481), substantial equivalence of the dS Breast l6ch (1.5 T & 3.1T) devices is based on similarities in intended use, design features,… | 2004 |
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?
- 2 of the 2 ancestors have a recall of any class.
- 3 other devices also cite its predicate K032576.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.OT MR scanners as an accessory to produce images of the breast, chest wall and axillary tissue, as an aid to diagnosis. The coil permits MR-guided breast biopsy and localization of lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122646: DS Breast 16CH I/T 1.5T DS Breast 16CH I/T 3.0T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122646
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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