Cleared Special

PRESTODR 4143

K110849 · Cmt Medical Technologies, Ltd. · Radiology
Apr 2011
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K110849 is an FDA 510(k) clearance for the PRESTODR 4143, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Cmt Medical Technologies, Ltd. (Yoqneam Ilit, IL). The FDA issued a Cleared decision on April 26, 2011, 29 days after receiving the submission on March 28, 2011. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K110849 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2011
Decision Date April 26, 2011
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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