510(k) · Cleared
CleareddS Sentinelle Breast 16ch 1.5T Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Corporation (Business Trade Name: Philips) · MOS Coil, Magnetic Resonance, Specialty
Cleared on Aug 8, 2022 as substantially equivalent to K112112 (Sentinel Medical, Inc., 2011) after a 252-day review. Its family tree reaches back 4 generations to 1999. 2 later devices descend from it.
- Decided
- Aug 8, 2022
- Review
- 252 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K993776 (1999). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK993776 Obc-300 Breast Array CoilMri Devices Corp. · 1999
- 3 generations backK060873 Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array…Sentinelle Medical, Inc. · 2006
- 2 generations backK100113 Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for…Sentinelle Medical, Inc. · 2010 · Recalled
- 1 generation backK112112 Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for…Sentinel Medical, Inc. · 2011
- This deviceK213735 dS Sentinelle Breast 16ch 1.5T CoilInvivo Corporation (Business Trade Name: Philips) · 2022
- Descendant · cites it directly · 0 of its ownK262330 dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast…Philips Medical Systems Nederland B.V. · 2026
- Descendant · cites it directly · 0 of its ownK233348 16 Breast CoilPhilips Medical System Nederlands B.V. · 2023
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 |
|---|---|---|---|---|---|
| −4 | K993776 | Obc-300 Breast Array Coil | Mri Devices Corp. | 1999 | — |
| −3 | K060873 | Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE… | Sentinelle Medical, Inc. | 2006 | — |
| −2 | K100113 | Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri… | Sentinelle Medical, Inc. | 2010 | 1 |
| −1 | K112112 | Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for Siemens 1.5/3T… | Sentinel Medical, Inc. | 2011 | — |
| 0 (this device) | K213735 | dS Sentinelle Breast 16ch 1.5T Coil | Invivo Corporation (Business Trade Name: Philips) | 2022 | — |
| +1 | K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS… | Philips Medical Systems Nederland B.V. | 2026 | — |
| +1 | K233348 | 16 Breast Coil | Philips Medical System Nederlands B.V. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K112112 | Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for Siemens 1.5/3T Mri SystemsSummary page 4…uct code: MOS Primary Predicate Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens Device: 1.5T/3T MRI Systems (K112112 – Aug 25, 2011) Device Description: The dS Sentinelle Breast 16ch 1.5T Coil is a receive only coil to be used on a… | 2011 |
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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K262330 (Philips Medical Systems Nederland B.V., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112112.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 dS Sentinelle Breast 16ch 1.5T Coil is intended to be used in conjunction with Philips 1.5T Magnetic Resonance Scanners to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures.
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/K213735 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213735: dS Sentinelle Breast 16ch 1.5T Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213735
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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