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510(k) K081976

IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION by Agfa Healthcare Corporation — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2008
Date Received
July 11, 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

Other clearances by Agfa Healthcare Corporation

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  • K073271 — ORTHOGON (December 5, 2007)
  • K072680 — DRYSTAR AXYS, MODEL EYZ4E (October 25, 2007)

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