Cleared Traditional

K192761 - Asimov-MKS Imaging System

K192761 is the FDA 510(k) clearance for Asimov-MKS Imaging System by Onlume, Inc.. It is a Class 2 General & Plastic Surgery device (product code IZI) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K192761 · Onlume, Inc. · General & Plastic Surgery device
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Jan 2020
Decision
109d
Days
Class 2
Risk

K192761 is an FDA 510(k) clearance for the Asimov-MKS Imaging System. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Onlume, Inc. (Madison, US). The FDA issued a Cleared decision on January 17, 2020 after a review of 109 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 892.1600 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Onlume, Inc. devices

Submission Details

510(k) Number K192761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date January 17, 2020
Days to Decision 109 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 115d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - IZI System, X-ray, Angiographic

All 97
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