510(k) · Cleared
Cleared16 Breast Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical System Nederlands B.V. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Oct 24, 2023 as substantially equivalent to K213735 (Invivo Corporation (Business Trade Name: Philips), 2022) after a 25-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Oct 24, 2023
- Review
- 25 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K993776 (1999). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK993776 Obc-300 Breast Array CoilMri Devices Corp. · 1999
- 4 generations backK060873 Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array…Sentinelle Medical, Inc. · 2006
- 3 generations backK100113 Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for…Sentinelle Medical, Inc. · 2010 · Recalled
- 2 generations backK112112 Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for…Sentinel Medical, Inc. · 2011
- 1 generation backK213735 dS Sentinelle Breast 16ch 1.5T CoilInvivo Corporation (Business Trade Name: Philips) · 2022
- This deviceK233348 16 Breast CoilPhilips Medical System Nederlands B.V. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K993776 | Obc-300 Breast Array Coil | Mri Devices Corp. | 1999 | — |
| −4 | K060873 | Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE… | Sentinelle Medical, Inc. | 2006 | — |
| −3 | K100113 | Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri… | Sentinelle Medical, Inc. | 2010 | 1 |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K213735 | dS Sentinelle Breast 16ch 1.5T CoilSummary page 5…Radiology Device Class: Class II Product Code: MOS Predicate Device Trade Name: dS Sentinelle Breast 16ch 1.5T Coil (K213735) Classification Name: Coil, Magnetic Resonance, Specialty Regulation Number: 21 CFR 892.1000 Revie… | 2022 |
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 24 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K213735.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 16 Breast Coil for Canon 1.5T MRI Scanners are 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 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/K233348 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233348: 16 Breast Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233348
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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