# K213727: dS Sentinelle Breast 16ch 3.0T Coil

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corporation (Business Trade Name: Philips)
- Decided: Aug 8, 2022 after 255 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: 4 generations back to K993776 (1999). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112112: Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for Siemens 1.5/3T Mri Systems, Sentinel Medical, Inc. (2011) Summary page 4.

## Most influential descendants
- 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 (2026), 0 descendants of its own

## Indications for use
The dS Sentinelle Breast 16ch 3T Coil are intended to be used in conjunction with Philips 3.0T 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.

Source page: https://510kreport.com/device/K213727
Methodology: https://510kreport.com/methodology