# K233348: 16 Breast Coil

- Pathway: 510(k) (Special)
- Applicant: Philips Medical System Nederlands B.V.
- Decided: Oct 24, 2023 after 25 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213735: dS Sentinelle Breast 16ch 1.5T Coil, Invivo Corporation (Business Trade Name: Philips) (2022) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K233348
Methodology: https://510kreport.com/methodology