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510(k) K071297

IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) by Agfa Healthcare Corp. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2007
Date Received
May 9, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Corp.

  • K071972 — ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS (July 30, 2007)
  • K071162 — AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS (May 8, 2007)

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