510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080564Substantially 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)

K080564 is the FDA 510(k) clearance record for SCANSCOPE XT SYSTEM, a class II device, cleared for Aperio Technologies 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 10 510(k) clearances for Leica Biosystems Imaging, Inc., from to . As of , FDA records show no recalls naming K080564.

Clearance record

Decision date
Received
(533 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
Aperio Technologies 1360 Park Center Dr., Vista 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