Cleared Traditional

SCANVIEW HER2/NEU FISH SYSTEM

K101291 · Applied Spectral Imaging , Ltd. · Pathology

Nov 2010

Decision

200d

Days

Class 2

Risk

About This 510(k) Submission

K101291 is an FDA 510(k) clearance for the SCANVIEW HER2/NEU FISH 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 , Ltd. (Haifa, IL). The FDA issued a Cleared decision on November 23, 2010, 200 days after receiving the submission on May 7, 2010. This device falls under the Pathology review panel. Regulated under 21 CFR 866.4700.

Submission Details

510(k) Number	K101291 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 07, 2010
Decision Date	November 23, 2010
Days to Decision	200 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