Home / 510(k) Clearances / K031715

510(k) K031715

ARIOL HER-2/NEU IHC by Applied Imaging Corp. — Product Code NOT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2004
Date Received
June 2, 2003
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 Applied Imaging Corp.

  • K043519 — ARIOL HER-2/NEU FISH (April 25, 2005)
  • K042542 — CYTOVISION FOR CEP XY (January 10, 2005)
  • K033200 — ARIOL (March 18, 2004)
  • K001420 — SLIDESCAN (August 30, 2000)
  • K980375 — WINSCAN AUTOMATED IMAGING SYSTEM (June 9, 1998)
  • K902311 — GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. (August 20, 1990)

Other clearances for product code NOT

  • K141109 — APERIO EPATHOLOGY EIHC IVD SYSTEM (July 29, 2014)
  • 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)
  • K071128 — SCANSCOPE XT SYSTEM (October 10, 2007)
  • K062756 — PATHIAM IMAGING SOFTWARE FOR HER2/NEU (February 20, 2007)
  • K051282 — VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU (August 16, 2005)