Cleared Traditional

SCANVIEW SYSTEM

K110345 · Applied Spectral Imaging · Pathology

Oct 2011

Decision

257d

Days

Class 2

Risk

About This 510(k) Submission

K110345 is an FDA 510(k) clearance for the SCANVIEW SYSTEM, a System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays (Class II — Special Controls, product code NTH), submitted by Applied Spectral Imaging (Haifa, IL). The FDA issued a Cleared decision on October 19, 2011, 257 days after receiving the submission on February 4, 2011. This device falls under the Pathology review panel. Regulated under 21 CFR 866.4700.

Submission Details

510(k) Number	K110345 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2011
Decision Date	October 19, 2011
Days to Decision	257 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	NTH — System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.4700