Cleared Traditional

DIGITAL DIAGNOSTIC X-RAY SYSTEM

K102408 · DRGEM Corporation · Radiology
Dec 2010
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K102408 is an FDA 510(k) clearance for the DIGITAL DIAGNOSTIC X-RAY SYSTEM, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by DRGEM Corporation (Echo, US). The FDA issued a Cleared decision on December 27, 2010, 126 days after receiving the submission on August 23, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K102408 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2010
Decision Date December 27, 2010
Days to Decision 126 days
Submission Type Traditional
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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