Cleared Special

PRESTODR PORTABLE

K100400 · Cmt Medical Technologies, Ltd. · Radiology
Apr 2010
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K100400 is an FDA 510(k) clearance for the PRESTODR PORTABLE, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Cmt Medical Technologies, Ltd. (Yoqneam Ilit, IL). The FDA issued a Cleared decision on April 22, 2010, 65 days after receiving the submission on February 16, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number K100400 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2010
Decision Date April 22, 2010
Days to Decision 65 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZL — System, X-ray, Mobile
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1720

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