VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51

Coil, Magnetic Resonance, Specialty

SENTINELLE MEDICAL, INC.

The following data is part of a premarket notification filed by Sentinelle Medical, Inc. with the FDA for Vanguard Breast Mri Auxiliary Table With 16 Channel Coil Array For Ge 3t Mri System, Model 4000451-51.

Pre-market Notification Details

• Device ID: K100113
• 510k Number: K100113
• Device Name: VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51
• Classification: Coil, Magnetic Resonance, Specialty
• Applicant: SENTINELLE MEDICAL, INC. 555 RICHMOND STREET W SUITE 800, PO BOX 301 Toronto, Ontario, CA M5v 3b1
• Contact: Joan Medley
• Correspondent: Joan Medley; SENTINELLE MEDICAL, INC. 555 RICHMOND STREET W SUITE 800, PO BOX 301 Toronto, Ontario, CA M5v 3b1
• Product Code: MOS
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-01-14
• Decision Date: 2010-04-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838081703	K100113	000
00884838081581	K100113	000
00884838080980	K100113	000
00884838080973	K100113	000
00884838080959	K100113	000