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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, Tomographic
510(k) Number K780319
Device Name ORBITOME-UG
Applicant
Philips Medical Systems (Cleveland), Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Philips Medical Systems (Cleveland), Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1740
Classification Product Code
IZF  
Date Received02/24/1978
Decision Date 03/14/1978
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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