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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K885242
Device Name MICRODELTA II
Applicant
Siemens Gammasonics, Inc.
2000 Nuclear Dr.
Des Plaines,  IL  60018
Applicant Contact MERRIBETH ADAMS
Correspondent
Siemens Gammasonics, Inc.
2000 Nuclear Dr.
Des Plaines,  IL  60018
Correspondent Contact MERRIBETH ADAMS
Regulation Number892.1100
Classification Product Code
IYX  
Date Received12/22/1988
Decision Date 03/30/1989
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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