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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, Angiographic
510(k) Number K170239
Device Name Leica FL560
Applicant
Leica Microsystems (Schweiz) AG
Max Schmidheiny - Strasse 201
Heerbrugg,  CH 9435
Applicant Contact GRAINNE GRIFFIN
Correspondent
Leica Microsystems (Schweiz) AG
Max Schmidheiny - Strasse 201
Heerbrugg,  CH 9435
Correspondent Contact GRAINNE GRIFFIN
Regulation Number892.1600
Classification Product Code
IZI  
Date Received01/26/2017
Decision Date 07/05/2017
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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