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
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K140957Substantially Equivalent

Genasis Hipath Ihc Family

Applied Spectral Imaging, Ltd., Caesarea, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140957 is the FDA 510(k) clearance record for GENASIS HIPATH IHC FAMILY, a class II device, cleared for Applied Spectral Imaging , Ltd. 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 8 510(k) clearances for Applied Spectral Imaging , Ltd., from to . As of , FDA records show no recalls naming K140957.

Clearance record

Decision date
Received
(276 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
Applied Spectral Imaging , Ltd. P.O. Box 4414 (A109), Caesarea, IL
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