1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL— 510(k) K140606

Substantially Equivalent

Resonance Innovations, LLC

FDA 510(k) clearance K140606 for 1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL, Substantially Equivalent on 2014-05-12. Applicant: Resonance Innovations, LLC. Device class: 2.

Clearance details

Applicant
Resonance Innovations, LLC
Product code
Code MOS
Device class
Class 2
Regulation
21 CFR 892.1000
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Omaha, NE, US
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