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

Name: FDA 510(k) clearance K112112
Creator: U.S. Food and Drug Administration
Published: 2011-08-25

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.. Device class: 2.

Clearance details

Applicant: Sentinel Medical, Inc.
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
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 ↗

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