Cleared Traditional

K260161 - SmartGuide Disposable Guides and Grids

K260161 is the FDA 510(k) clearance for SmartGuide Disposable Guides and Grids by UC-CARE , Ltd.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K260161 · UC-CARE , Ltd. · Radiology device
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Jul 2026
Decision
191d
Days
Class 2
Risk

K260161 is an FDA 510(k) clearance for the SmartGuide Disposable Guides and Grids. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by UC-CARE , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on July 30, 2026 after a review of 191 days - an extended review 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: 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 UC-CARE , Ltd. devices

Submission Details

510(k) Number K260161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2026
Decision Date July 30, 2026
Days to Decision 191 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
84d slower than avg
Panel avg: 107d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 182
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