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510(k) K071972

ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS by Agfa Healthcare Corp. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2007
Date Received
July 17, 2007
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 Corp.

  • K071297 — IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) (June 22, 2007)
  • K071162 — AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS (May 8, 2007)

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