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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K004037
Device Name X-RAY SYSTEM XR-MX
Applicant
Karl Storz Endoscopy
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact JENNIFER S PORTUGAL
Correspondent
Karl Storz Endoscopy
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact JENNIFER S PORTUGAL
Regulation Number892.1650
Classification Product Code
JAA  
Date Received12/28/2000
Decision Date 02/02/2001
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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