Cleared Traditional

RadGil2 (K201177) - FDA 510(k) Clearance

K201177 · R3 X-Ray L.L.C · Radiology device
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Aug 2020
Decision
108d
Days
-
Risk

K201177 is an FDA 510(k) clearance for the RadGil2. Classified as Irradiator, Blood To Prevent Graft Versus Host Disease (product code MOT).

Submitted by R3 X-Ray L.L.C (Tucson, US). The FDA issued a Cleared decision on August 17, 2020 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel. 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.

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Submission Details

510(k) Number K201177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2020
Decision Date August 17, 2020
Days to Decision 108 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
1d slower than avg
Panel avg: 107d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Device Class -