Cleared Traditional

K201177 - RadGil2 (FDA 510(k) Clearance)

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

K201177 is an FDA 510(k) clearance for the RadGil2. This device is classified as a Irradiator, Blood To Prevent Graft Versus Host Disease.

Submitted by R3 X-Ray L.L.C (Tucson, US). The FDA issued a Cleared decision on August 17, 2020, 108 days after receiving the submission on May 1, 2020.

This device falls under the Radiology FDA review panel.

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

Device Classification

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