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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K173076
Device Name CURA 16; ScintCare CT16
Applicant
Fmi Medical Systems, Inc.
29001 Solon Rd., Unit A
Solon,  OH  44139
Applicant Contact Scott LeMaster
Correspondent
FDA 510k Consultants, LLC
29001 Solon Rd., Unit A
Solon,  OH  44139
Correspondent Contact Paul McFeely
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/29/2017
Decision Date 10/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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