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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, Stationary
510(k) Number K841923
Device Name DCX-100 CHEST UNIT-GL-5000M
Applicant
Transworld X-Ray Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Transworld X-Ray Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1680
Classification Product Code
KPR  
Date Received05/10/1984
Decision Date 08/10/1984
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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