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510(k) K133135

IMPAX VOLUME VIEWING 3.0 by Agfa Healthcare N.V. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2014
Date Received
October 4, 2013
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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  • K152639 — DR 600 (December 11, 2015)
  • K143397 — ICIS View (June 1, 2015)
  • K142316 — IMPAX Agility (January 6, 2015)
  • K142184 — DX-D IMAGING PACKAGE (October 16, 2014)

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