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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K042133
Device Name DRY LASER IMAGER, MODEL DRYPRO MODEL 793
Applicant
Konica Minolta Medical & Graphic, Inc.
Progress Section
319 Akeno, Obata-Cho
Watarai-Gun; Mie-Ken,  JP 519-05
Applicant Contact SHINICHI YAMANAKA
Correspondent
Konica Minolta Medical & Graphic, Inc.
Progress Section
319 Akeno, Obata-Cho
Watarai-Gun; Mie-Ken,  JP 519-05
Correspondent Contact SHINICHI YAMANAKA
Regulation Number892.2040
Classification Product Code
LMC  
Date Received08/09/2004
Decision Date 11/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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