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510(k) K033200

ARIOL by Applied Imaging Corp. — Product Code NQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2004
Date Received
October 2, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Device Class
Class II
Regulation Number
864.1860
Review Panel
PA
Submission Type

Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.

Other clearances by Applied Imaging Corp.

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  • K001420 — SLIDESCAN (August 30, 2000)
  • K980375 — WINSCAN AUTOMATED IMAGING SYSTEM (June 9, 1998)
  • K902311 — GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. (August 20, 1990)

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  • K073677 — SCANSCOPE XT SYSTEM (August 1, 2008)
  • K061613 — VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) (January 10, 2007)