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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K972822
Device Name IMATION SE-204 LASER IMAGER
Applicant
Imation Enterprises Corp.
3m Center, Bldg. 235-2b-23
St. Paul,  MN  55144
Applicant Contact STEPHEN G SLAVENS
Correspondent
Imation Enterprises Corp.
3m Center, Bldg. 235-2b-23
St. Paul,  MN  55144
Correspondent Contact STEPHEN G SLAVENS
Regulation Number892.2040
Classification Product Code
LMC  
Date Received07/30/1997
Decision Date 11/19/1997
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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