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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K062376
Device Name DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI
Applicant
RF SYSTEMS LAB.
110 E. GRANADA BLVD.
SUITE 208
ORMOND BEACH,  FL  32164
Applicant Contact CLAUDE D BERTHOIN
Correspondent
RF SYSTEMS LAB.
110 E. GRANADA BLVD.
SUITE 208
ORMOND BEACH,  FL  32164
Correspondent Contact CLAUDE D BERTHOIN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/15/2006
Decision Date 10/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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