Cleared Traditional

K110856 - RALCO

K110856 is an FDA 510(k) clearance for RALCO, manufactured by Ralco S.R.L.. The device is a Class 2 Radiology device with product code IZX cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K110856 · Ralco S.R.L. · Radiology device
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Aug 2011
Decision
135d
Days
Class 2
Risk

K110856 is an FDA 510(k) clearance for the RALCO. Classified as Collimator, Manual, Radiographic (product code IZX), Class II - Special Controls.

Submitted by Ralco S.R.L. (Naples, US). The FDA issued a Cleared decision on August 10, 2011 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1610 - 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 Ralco S.R.L. devices

FDA 510(k) Submission Details - K110856

510(k) Number K110856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2011
Decision Date August 10, 2011
Days to Decision 135 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
28d slower than avg
Panel avg: 107d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZX Device Classification - Class 2, Special Controls

Product Code IZX Collimator, Manual, Radiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1610
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 - IZX Collimator, Manual, Radiographic

Devices cleared under the same product code (IZX) and FDA review panel - the closest regulatory comparables to K110856.
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