510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080909Substantially Equivalent

Iconoscope Oncofish Her2 Test System, Model 2000

Ikonisys, Inc., New Haven CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080909 is the FDA 510(k) clearance record for ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000, a class II device, cleared for Ikonisys, Inc. on under FDA product code NTH (System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays). FDA records list 4 510(k) clearances for Ikonisys, Inc., from to . As of , FDA records show no recalls naming K080909.

Clearance record

Decision date
Received
(199 days to decision)
Product code
NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Regulation
21 CFR 866.4700
Device class
Class II
Review panel
Immunology
Applicant
Ikonisys, Inc. 5 Science Park, New Haven CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTH

Trailing 12 months

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

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