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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K955232
Device Name NT SERIES DIGITAL IMAGE MANAGER
Applicant
Camtronics, Ltd.
900 Walnut Ridge Dr.
P.O. Box 950
Hartland,  WI  53029
Applicant Contact ROBERT KRIEDERMANN
Correspondent
Camtronics, Ltd.
900 Walnut Ridge Dr.
P.O. Box 950
Hartland,  WI  53029
Correspondent Contact ROBERT KRIEDERMANN
Regulation Number892.2010
Classification Product Code
LMB  
Date Received11/14/1995
Decision Date 12/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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