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510(k) K062756

PATHIAM IMAGING SOFTWARE FOR HER2/NEU by Bioimagene, Inc. — Product Code NOT

K062756 is an FDA 510(k) premarket notification submitted by Bioimagene, Inc. for the device "PATHIAM IMAGING SOFTWARE FOR HER2/NEU". The FDA issued a decision of Substantially Equivalent on February 20, 2007. 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 20, 2007
Date Received
September 14, 2006
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)
  • K080910 — PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS (February 4, 2009)

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)
  • K080910 — PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS (February 4, 2009)
  • K071128 — SCANSCOPE XT SYSTEM (October 10, 2007)
  • K051282 — VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU (August 16, 2005)

FDA data resources