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510(k) K041270

CT COLONOGRAPHY II by General Electric Medical Systems — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2004
Date Received
May 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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