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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K893379
Device Name XENOS MOBILECAM
Applicant
Xenos Medical Systems, Inc.
P.O. Box 16598
Fort Worth,  TX  76162
Applicant Contact RICHARD HAMER
Correspondent
Xenos Medical Systems, Inc.
P.O. Box 16598
Fort Worth,  TX  76162
Correspondent Contact RICHARD HAMER
Regulation Number892.1100
Classification Product Code
IYX  
Date Received05/01/1989
Decision Date 08/11/1989
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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