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
K080254Substantially Equivalent

Scanscope Xt System

Leica Biosystems Imaging, Inc., Vista CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080254 is the FDA 510(k) clearance record for SCANSCOPE XT SYSTEM, a class II device, cleared for Aperio Technologies on under FDA product code OEO (Automated Digital Image Manual Interpretation Microscope). FDA's definition for product code OEO reads: "The ihc her2 manual read of a digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of her2/neu (c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic...". FDA records list 10 510(k) clearances for Leica Biosystems Imaging, Inc., from to . As of , FDA records show no recalls naming K080254.

Clearance record

Decision date
Received
(274 days to decision)
Product code
OEO Automated Digital Image Manual Interpretation Microscope
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Aperio Technologies 1430 Vantage Ct., Vista CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OEO

Trailing 12 months

FDA records hold no clearances under product code OEO in the trailing twelve months.

FDA records show no clearances under product code OEO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OEO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260