1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS— 510(k) K093689

Name: FDA 510(k) clearance K093689
Creator: U.S. Food and Drug Administration
Published: 2010-08-31

Substantially Equivalent

Mr Medical Solutions, LLC

FDA 510(k) clearance K093689 for 1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS, Substantially Equivalent on 2010-08-31. Applicant: Mr Medical Solutions, LLC. Device class: 2.

Clearance details

Applicant: Mr Medical Solutions, LLC
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2009-11-30
Decision date: 2010-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburg, PA, US

Download summary PDF View on FDA.gov ↗

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