510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110345Substantially Equivalent

Scanview System

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

K110345 is the FDA 510(k) clearance record for SCANVIEW SYSTEM, a class II device, cleared for Applied Spectral Imaging on under FDA product code NTH (System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays). FDA records list 8 510(k) clearances for Applied Spectral Imaging, from to . As of , FDA records show no recalls naming K110345.

Clearance record

Decision date
Received
(257 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
Applied Spectral Imaging 6 Sireni, Haifa, 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