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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 K192761
Device Name Asimov-MKS Imaging System
Applicant
Onlume, Inc.
3300 Commercial Ave.
Madison,  WI  53714
Applicant Contact Greg Bange
Correspondent
Onlume, Inc.
3300 Commercial Ave.
Madison,  WI  53714
Correspondent Contact Greg Bange
Regulation Number892.1600
Classification Product Code
IZI  
Date Received09/30/2019
Decision Date 01/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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