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
K073677Substantially 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)

K073677 is the FDA 510(k) clearance record for SCANSCOPE XT SYSTEM, a class II device, cleared for Aperio Technologies on under FDA product code NQN (Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity). FDA's definition for product code NQN reads: "Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention". FDA records list 10 510(k) clearances for Leica Biosystems Imaging, Inc., from to . As of , FDA records show no recalls naming K073677.

Clearance record

Decision date
Received
(217 days to decision)
Product code
NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Aperio Technologies 1430 Vantage Ct., Suite 106, Vista CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQN

Trailing 12 months

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

FDA records show no clearances under product code NQN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NQN, 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