Cleared Traditional

K192170 - VistaScan USB Ultrasound Imaging System

K192170 is the FDA 510(k) clearance for VistaScan USB Ultrasound Imaging System by Emagine Solutions Technology, LLC. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K192170 · Emagine Solutions Technology, LLC · Radiology device
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Jan 2020
Decision
164d
Days
Class 2
Risk

K192170 is an FDA 510(k) clearance for the VistaScan USB Ultrasound Imaging System. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Emagine Solutions Technology, LLC (Tucson, US). The FDA issued a Cleared decision on January 23, 2020 after a review of 164 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Emagine Solutions Technology, LLC devices

Submission Details

510(k) Number K192170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2019
Decision Date January 23, 2020
Days to Decision 164 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 107d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Radiology devices follow this clearance model.

Regulatory Consultant

leanRAQA, LLC
Michelle Lott

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 387
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