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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 K011290
Device Name PROGNOST ES, MODEL 0302 0000
Applicant
Xmar Corp.
2222 Delaware Dr.
Cleveland Heights,  OH  44106
Applicant Contact NEIL BARRETT
Correspondent
Xmar Corp.
2222 Delaware Dr.
Cleveland Heights,  OH  44106
Correspondent Contact NEIL BARRETT
Regulation Number892.1740
Classification Product Code
IZF  
Date Received04/27/2001
Decision Date 05/30/2001
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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