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510(k) K260755

OptraSCAN System by Optrascan, Inc. — Product Code NOT

K260755 is an FDA 510(k) premarket notification submitted by Optrascan, Inc. for the device "OptraSCAN System". The FDA issued a decision of Substantially Equivalent on July 2, 2026. The device falls under product code NOT (Microscope, Automated, Image Analysis, Operator Intervention), a Class II device regulated under 21 CFR 864.1860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2026
Date Received
March 9, 2026
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 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)
  • 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