Breast BI 7 MR Coil Mammavention 3T— 510(k) K162651

Name: FDA 510(k) clearance K162651
Creator: U.S. Food and Drug Administration
Published: 2017-01-18

Substantially Equivalent

Moras Mri Products GmbH

FDA 510(k) clearance K162651 for Breast BI 7 MR Coil Mammavention 3T, Substantially Equivalent on 2017-01-18. Applicant: Moras Mri Products GmbH. Device class: 2.

Clearance details

Applicant: Moras Mri Products GmbH
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2016-09-23
Decision date: 2017-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoechberg, DE

Download summary PDF View on FDA.gov ↗

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