510(k) Report

510(k) · Cleared

Cleared

dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T

K262330510(k) SpecialCleared Jul 30, 202621-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Philips Medical Systems Nederland B.V. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Jul 30, 2026 as substantially equivalent to K232762 (Invivo Corporation (Business Trade Name: Philips), 2023) and 5 other predicates after a 21-day review. Its family tree reaches back 5 generations to 1999.

Decided
Jul 30, 2026
Review
21 days
Class
Class II
Product code
MOS
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K993776 (1999). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2023: 1 other ancestor2022: 1 other ancestor2007: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor2001: 1 other ancestorReference device: K222325 · 8ch Wrist Coil · Invivo Corporation (Business Trade Name: Philips) · 2022K993776 · Obc-300 Breast Array Coil · Mri Devices Corp. · 1999K060873 · Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa Systems · Sentinelle Medical, Inc. · 2006K100113 · Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System, Model 4000451-51 · Sentinelle Medical, Inc. · 2010 · recalledK112112 · Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for Siemens 1.5/3T Mri Systems · Sentinel Medical, Inc. · 2011K213735 · dS Sentinelle Breast 16ch 1.5T Coil · Invivo Corporation (Business Trade Name: Philips) · 20221995200020052010201520202025
Other ancestors, by generation 1 generation back: 5 other ancestors5 generations back: 1 other ancestor K213735 · dS Sentinelle Breast 16ch 1.5T Coil · Invivo Corporation (Business Trade Name: Philips) · 2022K112112 · Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for Siemens 1.5/3T Mri Systems · Sentinel Medical, Inc. · 2011K100113 · Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System, Model 4000451-51 · Sentinelle Medical, Inc. · 2010 · recalledK060873 · Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa Systems · Sentinelle Medical, Inc. · 2006K993776 · Obc-300 Breast Array Coil · Mri Devices Corp. · 1999−50
  1. Root · 5 generations backK993776 Obc-300 Breast Array CoilMri Devices Corp. · 1999
  2. 4 generations backK060873 Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array…Sentinelle Medical, Inc. · 2006
  3. 3 generations backK100113 Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for…Sentinelle Medical, Inc. · 2010 · Recalled
  4. 2 generations backK112112 Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for…Sentinel Medical, Inc. · 2011
  5. 1 generation backK213735 dS Sentinelle Breast 16ch 1.5T CoilInvivo Corporation (Business Trade Name: Philips) · 2022
  6. This deviceK262330 dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast…Philips Medical Systems Nederland B.V. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K993776Obc-300 Breast Array CoilMri Devices Corp.1999—
−4K060873Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE…Sentinelle Medical, Inc.2006—
−3K100113Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri…Sentinelle Medical, Inc.20101
−2K112112Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for Siemens 1.5/3T…Sentinel Medical, Inc.2011—
−1K213735dS Sentinelle Breast 16ch 1.5T CoilInvivo Corporation (Business Trade Name: Philips)2022—
0 (this device)K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS…Philips Medical Systems Nederland B.V.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200310
200410
200710
202210
202310
FIG. 1 — Lineage of K262330, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K232762dS Breast Coil 7ch 1.5T
Summary page 5
…0252227 Device(s) Predicate Device(s) Trade Name: dS Breast Coil 7ch 1.5T dS Breast Coil 7ch 1.5T - K232762 dS Breast 7ch 1.5T Model BBC Biopsy Breast Coil -…
Invivo Corporation (Business Trade Name: Philips)2023—
*K032576Biopsy Breast Coil, Model BBC
Summary page 5
…Coil 7ch 1.5T - K232762 dS Breast 7ch 1.5T Model BBC Biopsy Breast Coil - K032576 dS Breast 7ch 3.0T Model BBC-127-ACHIEVA Biopsy…
Mri Devices Corp.20034
*K041481Model BBC-127 Biopsy Breast Coil
Summary page 5
…K032576 dS Breast 7ch 3.0T Model BBC-127-ACHIEVA Biopsy Breast Coil - K041481 dS Breast 16ch 1.5T LBS-63-16 Breast Array Coil - dS Breast 16ch 3.0T…
Mri Devices Corp.20041
*K072873LBS-63-16 Breast Array Coil
Summary page 5
…Breast Coil - K041481 dS Breast 16ch 1.5T LBS-63-16 Breast Array Coil - dS Breast 16ch 3.0T K072873 dS Sentinelle Breast 16ch 1.5T dS Sentinelle Breast 16ch 1.5T -…
Invivo20074
*K213735dS Sentinelle Breast 16ch 1.5T Coil
Summary page 5
…K072873 dS Sentinelle Breast 16ch 1.5T dS Sentinelle Breast 16ch 1.5T - K213735 dS Sentinelle Breast 16ch 3.0T dS Sentinelle Breast 16ch 3.0T -…
Invivo Corporation (Business Trade Name: Philips)2022—
*K213727dS Sentinelle Breast 16ch 3.0T Coil
Summary page 6
…213735 dS Sentinelle Breast 16ch 3.0T dS Sentinelle Breast 16ch 3.0T - K213727 Manufacturer: Philips Medical Systems Nederland B.V. Classification Name: Coil, Magnetic Resonance, Specialty Regulati…
Invivo Corporation (Business Trade Name: Philips)2022—
†K2223258ch Wrist CoilInvivo Corporation (Business Trade Name: Philips)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 27 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
  • 4 of the 11 ancestors have a recall of any class.

How does its category compare?

All MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · MOS

3in 2025

2007: 162008: 192009: 102010: 162011: 252012: 152013: 72014: 122015: 62016: 112017: 92018: 102019: 32020: 52021: 42022: 112023: 102024: 102025: 32026 (partial year): 10
2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007: 19 days median2008: 33 days median2009: 43 days median2010: 78 days median2011: 57 days median2012: 49 days median2013: 87 days median2014: 60 days median2015: 58 days median2016: 42 days median2017: 63 days median2018: 30 days median2019: 178 days median2020: 51 days median2021: 41 days median2022: 79 days median2023: 59 days median2024: 39 days median2025: 59 days median2026 (partial year): 45 days median
2007high 178 (2019) · low 19 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MOS

13in 2024

2008: 22010: 12012: 12015: 22019: 82020: 12024: 13
2007high 13 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MOS

2in 2025

2007: 42008: 22009: 52010: 132011: 72012: 122013: 102014: 42015: 52016: 72017: 92018: 72019: 82020: 22021: 32022: 52023: 42024: 82025: 2
2007high 13 (2010) · low 2 (2008)2025

MAUDE reports naming product code MOS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007161904
2008193322
2009104305
20101678113
2011255707
20121549112
2013787010
2014126004
201565825
2016114207
201796309
2018103007
2019317888
202055112
202144103
2022117905
2023105904
20241039138
202535902
202610450—

What is it indicated for?

The dS Breast Coil 7ch 1.5T is intended to be used in conjunction with a Philips Prodiva 1.5T CS, Prodiva 1.5T CX, and a MR 5300 1.5T Magnetic Resonance Scanner in adult and adolescent patients to produce diagnostic images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician. The Philips dS Breast 7ch 1.5T & 3.0T Coil is to be used in conjunction with a Philips 1.5T & 3.0T Magnetic Resonance Scanner in adult and…

Read the full statement (218 words)

The dS Breast Coil 7ch 1.5T is intended to be used in conjunction with a Philips Prodiva 1.5T CS, Prodiva 1.5T CX, and a MR 5300 1.5T Magnetic Resonance Scanner in adult and adolescent patients to produce diagnostic images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

The Philips dS Breast 7ch 1.5T & 3.0T Coil is to be used in conjunction with a Philips 1.5T & 3.0T Magnetic Resonance Scanner in adult and adolescent patients to produce diagnostic images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

The Philips dS Breast 16ch 1.5T & 3.0T Coil is to be used in conjunction with a Philips 1.5T & 3.0T Magnetic Resonance Scanner in adult and adolescent patients to produce diagnostic images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

The dS Sentinelle 16ch 1.5T & 3.0T Coil for Philips Ingenia 1.5T & 3.0T MRI Systems are designed to provide magnetic resonance images of breast anatomy when used in conjunction with a magnetic resonance scanner in adult and adolescent patients. A trained physician interprets these images. When used with a disposable biopsy grid, the coil 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.

More from Philips Medical Systems Nederland B.V.

107 FDA decisions under this applicant name. See the company

  • K254205Zenition 30Philips Medical Systems Nederland B.V. · 2026
  • K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS…Philips Medical Systems Nederland B.V. · 2026
  • K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V. · 2026
  • K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V. · 2026
  • K260169AV Cardiac CTPhilips Medical Systems Nederland B.V. · 2026

Recent decisions in MOS

The MOS category page

  • K262813InkSpace Imaging Small Body Array (SBA12PH15x)Inkspace Imaging, Inc. · 2026
  • K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS…Philips Medical Systems Nederland B.V. · 2026
  • K2609470.55T 12Ch Breast CoilNeocoil, LLC · 2026
  • K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd. · 2026
  • K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S…Shenzhen RF Tech Co., Ltd. · 2026

https://510kreport.com/device/K262330 · printed Nov 6, 2026

Cite this page

510(k) Report. “K262330: dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 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/K262330

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026