Cleared Traditional

K120156 - PUREIMAGE ULTRASOUND TRANSMISSION GEL

K120156 is an FDA 510(k) clearance for PUREIMAGE ULTRASOUND TRANSMISSION GEL, manufactured by Medline. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K120156 · Medline · Radiology device
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Feb 2012
Decision
21d
Days
Class 2
Risk

K120156 is an FDA 510(k) clearance for the PUREIMAGE ULTRASOUND TRANSMISSION GEL. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Medline (Mundelein, US). The FDA issued a Cleared decision on February 8, 2012 after a review of 21 days - a notably fast clearance cycle.

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: 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 Medline devices

FDA 510(k) Submission Details - K120156

510(k) Number K120156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2012
Decision Date February 08, 2012
Days to Decision 21 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
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.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 259
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K120156.
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