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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 K980826
Device Name EQUIDOSE SOLID STATE DIODE DETECTORS
Applicant
Cii Mastek, Inc.
1465 Cypress Ave.
Melbourne,  FL  32935
Applicant Contact JORGE A FERNANDEZ
Correspondent
Cii Mastek, Inc.
1465 Cypress Ave.
Melbourne,  FL  32935
Correspondent Contact JORGE A FERNANDEZ
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/03/1998
Decision Date 06/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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