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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K974770
Device Name ACQPLAN
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
CLEVELAND,  OH  44143
Applicant Contact ROBERT L TUROCY
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
CLEVELAND,  OH  44143
Correspondent Contact ROBERT L TUROCY
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received12/22/1997
Decision Date 09/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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