510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K260755Substantially Equivalent

OptraSCAN System

OptraSCAN Inc., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260755 is the FDA 510(k) clearance record for OptraSCAN System, a class II device, cleared for Optrascan, Inc. on under FDA product code NOT (Microscope, Automated, Image Analysis, Operator Intervention). FDA's definition for product code NOT reads: "Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention". FDA records list one 510(k) clearance for Optrascan, Inc. As of , FDA records show no recalls naming K260755.

Clearance record

Decision date
Received
(115 days to decision)
Product code
NOT Microscope, Automated, Image Analysis, Operator Intervention
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Optrascan, Inc. 2001 Gateway Pl., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NOT

Trailing 12 months
1 clearance under product code NOT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NOT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260