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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 K892653
Device Name TOMAX ULTRASCAN
Applicant
Incubation Industries, Inc.
1308 Meetinghouse Rd.
Gwynedd,  PA  19436
Applicant Contact ANTHONY D FOSSILE
Correspondent
Incubation Industries, Inc.
1308 Meetinghouse Rd.
Gwynedd,  PA  19436
Correspondent Contact ANTHONY D FOSSILE
Regulation Number892.1740
Classification Product Code
IZF  
Date Received04/13/1989
Decision Date 08/28/1989
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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