Cleared Special

ArtPIX DRF

K202235 · Cmt Medical Technologies, Ltd. · Radiology
Sep 2020
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K202235 is an FDA 510(k) clearance for the ArtPIX DRF, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Cmt Medical Technologies, Ltd. (Yokneam Ilit, IL). The FDA issued a Cleared decision on September 3, 2020, 27 days after receiving the submission on August 7, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K202235 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2020
Decision Date September 03, 2020
Days to Decision 27 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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