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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K153593
Device Name CliniscanSM MRI
Applicant
Picofemto, LLC
228 E. 45th St.
New York,  NY  10017
Applicant Contact Jessica Phillips
Correspondent
Picofemto, LLC
228 E. 45th St.
New York,  NY  10017
Correspondent Contact Jessica Phillips
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/16/2015
Decision Date 02/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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