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510(k) K073677

SCANSCOPE XT SYSTEM by Aperio Technologies — Product Code NQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2008
Date Received
December 28, 2007
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 Aperio Technologies

  • K080564 — SCANSCOPE XT SYSTEM (August 14, 2009)
  • K080254 — SCANSCOPE XT SYSTEM (October 31, 2008)
  • K071671 — SCANSCOPE XT SYSTEM (December 28, 2007)
  • K071128 — SCANSCOPE XT SYSTEM (October 10, 2007)

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