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510(k) K080013

REGISTRATION AND FUSION by Agfa Healthcare Corporation — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2008
Date Received
January 3, 2008
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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  • K072680 — DRYSTAR AXYS, MODEL EYZ4E (October 25, 2007)

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