Cleared Traditional

K163026 - Ultra/Phonic Scanning Gel (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163026 · Pharmaceutical Innovations, Inc. · Radiology device
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Jan 2018
Decision
435d
Days
Class 2
Risk

K163026 is an FDA 510(k) clearance for the Ultra/Phonic Scanning Gel. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Pharmaceutical Innovations, Inc. (Newark, US). The FDA issued a Cleared decision on January 9, 2018 after a review of 435 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Pharmaceutical Innovations, Inc. devices

Submission Details

510(k) Number K163026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2016
Decision Date January 09, 2018
Days to Decision 435 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
328d slower than avg
Panel avg: 107d · This submission: 435d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUI Media, Coupling, Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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.