# 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

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jul 30, 2026 after 21 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K993776 (1999). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232762: dS Breast Coil 7ch 1.5T, Invivo Corporation (Business Trade Name: Philips) (2023) Summary page 5.
- K032576: Biopsy Breast Coil, Model BBC, Mri Devices Corp. (2003) Summary page 5.
- K041481: Model BBC-127 Biopsy Breast Coil, Mri Devices Corp. (2004) Summary page 5.
- K072873: LBS-63-16 Breast Array Coil, Invivo (2007) Summary page 5.
- K213735: dS Sentinelle Breast 16ch 1.5T Coil, Invivo Corporation (Business Trade Name: Philips) (2022) Summary page 5.
- K213727: dS Sentinelle Breast 16ch 3.0T Coil, Invivo Corporation (Business Trade Name: Philips) (2022) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K262330
Methodology: https://510kreport.com/methodology