FDA 510(k) Application Details - K062376

Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)

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510(K) Number K062376
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant RF SYSTEMS LAB.
110 E. GRANADA BLVD.
SUITE 208
ORMOND BEACH, FL 32164 US
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Contact CLAUDE D BERTHOIN
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Regulation Number 892.1650

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Classification Product Code MQB
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Date Received 08/15/2006
Decision Date 10/27/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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