Cleared Traditional

DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA

K093640 · Electron Jsco. · Radiology

Apr 2011

Decision

521d

Days

Class 2

Risk

About This 510(k) Submission

K093640 is an FDA 510(k) clearance for the DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA, a System, Imaging, X-ray, Electrostatic (Class II — Special Controls, product code IXK), submitted by Electron Jsco. (Great Neck, US). The FDA issued a Cleared decision on April 29, 2011, 521 days after receiving the submission on November 24, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1630.

Submission Details

510(k) Number	K093640 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2009
Decision Date	April 29, 2011
Days to Decision	521 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF