SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS— 510(k) K112112

Substantially Equivalent

Sentinel Medical, Inc.

FDA 510(k) clearance K112112 for SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS, Substantially Equivalent on 2011-08-25. Applicant: Sentinel Medical, Inc..

Clearance details

Applicant: Sentinel Medical, Inc.
Product code: Code MOS
Advisory panel: Radiology
Date received: 2011-07-25
Decision date: 2011-08-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.