# K112112: Sentinelle Breast Mri Tabletop with 16 Channel Coil Array for Siemens 1.5/3T Mri Systems

- Pathway: 510(k) (Special)
- Applicant: Sentinel Medical, Inc.
- Decided: Aug 25, 2011 after 31 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: 3 generations back to K993776 (1999). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100113: Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System, Model 4000451-51, Sentinelle Medical, Inc. (2010) Summary page 3.

## Most influential descendants
- K213735: dS Sentinelle Breast 16ch 1.5T Coil (2022), 2 descendants of its own
- K213727: dS Sentinelle Breast 16ch 3.0T Coil (2022), 1 descendant of its own
- 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
- K233348: 16 Breast Coil (2023), 0 descendants of its own

## Indications for use
The Sentinelle Breast MRI tabletop with 16 Channel Coil Array for Siemens 1.5T/3T MRI Systems is 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 sterile plate (biopsy grid), the device permits access to breast anatomy for biopsy and localization procedures.

Source page: https://510kreport.com/device/K112112
Methodology: https://510kreport.com/methodology