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510(k) K071128

SCANSCOPE XT SYSTEM by Aperio Technologies — Product Code NOT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2007
Date Received
April 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Automated, Image Analysis, Operator Intervention
Device Class
Class II
Regulation Number
864.1860
Review Panel
PA
Submission Type

Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.

Other clearances by Aperio Technologies

  • K080564 — SCANSCOPE XT SYSTEM (August 14, 2009)
  • K080254 — SCANSCOPE XT SYSTEM (October 31, 2008)
  • K073677 — SCANSCOPE XT SYSTEM (August 1, 2008)
  • K071671 — SCANSCOPE XT SYSTEM (December 28, 2007)

Other clearances for product code NOT

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  • K121033 — VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (September 6, 2013)
  • K121350 — VIRTUSO SYSTEM FOR IHC (DO-7) (June 1, 2012)
  • K111755 — VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (February 22, 2012)
  • K111543 — VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) (October 12, 2011)
  • K080564 — SCANSCOPE XT SYSTEM (August 14, 2009)
  • K080910 — PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS (February 4, 2009)
  • K062756 — PATHIAM IMAGING SOFTWARE FOR HER2/NEU (February 20, 2007)
  • K051282 — VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU (August 16, 2005)
  • K031715 — ARIOL HER-2/NEU IHC (January 8, 2004)