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510(k) K192761

Asimov-MKS Imaging System by Onlume, Inc. — Product Code IZI

K192761 is an FDA 510(k) premarket notification submitted by Onlume, Inc. for the device "Asimov-MKS Imaging System". The FDA issued a decision of Substantially Equivalent on January 17, 2020. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2020
Date Received
September 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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FDA data resources