510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130775Substantially Equivalent

Duet System

Bioview, Kfar Saba, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130775 is the FDA 510(k) clearance record for DUET SYSTEM, a class II device, cleared for Bioview , Ltd. on under FDA product code NTH (System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays). FDA records list 5 510(k) clearances for Bioview , Ltd., from to . As of , FDA records show no recalls naming K130775.

Clearance record

Decision date
Received
(415 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
Bioview , Ltd. 25a Sirkin St., Kfar Saba, IL
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