Cleared Traditional

K173547 - ImagenUniversal

K173547 is the FDA 510(k) clearance for ImagenUniversal by Cardiovascular Imaging Technologies. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K173547 · Cardiovascular Imaging Technologies · Radiology device
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Jan 2018
Decision
57d
Days
Class 2
Risk

K173547 is an FDA 510(k) clearance for the ImagenUniversal. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Cardiovascular Imaging Technologies (Kansas City, US). The FDA issued a Cleared decision on January 12, 2018 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardiovascular Imaging Technologies devices

Submission Details

510(k) Number K173547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2017
Decision Date January 12, 2018
Days to Decision 57 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
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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

Pra Health Sciences
Melanie K. Hasek

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 - KPS System, Tomography, Computed, Emission

All 242
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