510(k) · Cleared
ClearedSentinelle Breast Mri Tabletop with 16 Channel Coil Array for Siemens 1.5/3T Mri Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sentinel Medical, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Aug 25, 2011 as substantially equivalent to K100113 (Sentinelle Medical, Inc., 2010) after a 31-day review. Its family tree reaches back 3 generations to 1999. 4 later devices descend from it.
- Decided
- Aug 25, 2011
- Review
- 31 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993776 (1999). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK993776 Obc-300 Breast Array CoilMri Devices Corp. · 1999
- 2 generations backK060873 Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array…Sentinelle Medical, Inc. · 2006
- 1 generation backK100113 Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for…Sentinelle Medical, Inc. · 2010 · Recalled
- This deviceK112112 Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for…Sentinel Medical, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK213735 dS Sentinelle Breast 16ch 1.5T CoilInvivo Corporation (Business Trade Name: Philips) · 2022
- Descendant · cites it directly · 1 of its ownK213727 dS Sentinelle Breast 16ch 3.0T CoilInvivo Corporation (Business Trade Name: Philips) · 2022
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK233348 16 Breast CoilPhilips Medical System Nederlands B.V. · 2023
Most influential descendants
Showing 4 of 4 · See all- K213735dS Sentinelle Breast 16ch 1.5T CoilInvivo Corporation (Business Trade Name: Philips) · 2022 · cites it directly2descendants
- K213727dS Sentinelle Breast 16ch 3.0T CoilInvivo Corporation (Business Trade Name: Philips) · 2022 · cites it directly1descendant
- K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…Philips Medical Systems Nederland B.V. · 2026 · 2 generations on0descendants
- K23334816 Breast CoilPhilips Medical System Nederlands B.V. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993776 | Obc-300 Breast Array Coil | Mri Devices Corp. | 1999 | — |
| −2 | K060873 | Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE… | Sentinelle Medical, Inc. | 2006 | — |
| −1 | K100113 | Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri… | Sentinelle Medical, Inc. | 2010 | 1 |
| 0 (this device) | K112112 | Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for Siemens 1.5/3T… | Sentinel Medical, Inc. | 2011 | — |
| +1 | K213735 | dS Sentinelle Breast 16ch 1.5T Coil | Invivo Corporation (Business Trade Name: Philips) | 2022 | — |
| +1 | K213727 | dS Sentinelle Breast 16ch 3.0T Coil | Invivo Corporation (Business Trade Name: Philips) | 2022 | — |
| +2 | 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 | — |
| +2 | 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 |
|---|---|---|
| 2022 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K100113 | Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System…Summary page 3…July 15, 2011 to predicate devices used for breast MRI imaging and intervention, including our legally marketed device [5 10(K) Number: K1001 131. The Sentinelle phased array breast coil set consists of 2, 10 or 16 RF coil elements in a phased array design. The coil eleme… | 2010 |
What descends from it? (4)
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 12 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K213735 (Invivo Corporation (Business Trade Name: Philips), 2022) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K100113.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Sentinelle Breast MRI tabletop with 16 Channel Coil Array for Siemens 1.5T/3T MRI Systems is designed to provide magnetic resonance images of breast anatomy when used in conjunction with a Magnetic Resonance Scanner. These images are interpreted by a trained physician. When used with a disposable sterile plate (biopsy grid), the device permits access to breast anatomy for biopsy and localization procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112112: Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for Siemens 1.5/3T Mri Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112112
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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