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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K873398
Device Name EXL-22DP X-RAY RADIATION THERAPY SYSTEM
Applicant
Mitsubishi Intl. Corp.
Suite 2730
1700 Market St.
Philadelphia,  PA  19103
Applicant Contact PAUL B WEBER
Correspondent
Mitsubishi Intl. Corp.
Suite 2730
1700 Market St.
Philadelphia,  PA  19103
Correspondent Contact PAUL B WEBER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/24/1987
Decision Date 04/29/1988
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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