# K100113: Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System, Model 4000451-51

- Pathway: 510(k) (Special)
- Applicant: Sentinelle Medical, Inc.
- Decided: Apr 22, 2010 after 98 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993776 (1999). 4 ancestors in all.
227 later devices descend from it; 3 cite it directly.
19 of 232 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060873: Vanguard Mri Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa Systems, Sentinelle Medical, Inc. (2006) Summary page 2.

## Most influential descendants
- K111242: Magnetom Aera and Magnetom Skyra (2011), 220 descendants of its own
- K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio (2012), 215 descendants of its own
- K141977: Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel (2014), 115 descendants of its own
- K151579: MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit (2015), 85 descendants of its own
- K153343: MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit (2016), 84 descendants of its own

## Recalls of this device
- May 6, 2016 · Class II · Z-2688-2016: A diode was inadvertently not assembled into the system, which may result in coil overheating

## Indications for use
The Sentinelle Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 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 can be interpreted by a trained physician. When used with a sterile fenestrated plate, this device permits access to the breast anatomy for biopsy and localization procedures that can be performed by a trained physician.

Source page: https://510kreport.com/device/K100113
Methodology: https://510kreport.com/methodology