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510(k) K080910

PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS by Bioimagene, Inc. — Product Code NOT

K080910 is an FDA 510(k) premarket notification submitted by Bioimagene, Inc. for the device "PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS". The FDA issued a decision of Substantially Equivalent on February 4, 2009. The device falls under product code NOT (Microscope, Automated, Image Analysis, Operator Intervention), a Class II device regulated under 21 CFR 864.1860. Bioimagene, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2009
Date Received
April 1, 2008
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 Bioimagene, Inc.

  • K092333 — PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 (October 27, 2010)
  • K062756 — PATHIAM IMAGING SOFTWARE FOR HER2/NEU (February 20, 2007)

Other clearances for product code NOT

  • K260755 — OptraSCAN System (July 2, 2026)
  • 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)
  • 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)

FDA data resources