Cleared Traditional

GENASIS SCANVIEW SYSTEM

K122554 · Applied Spectral Imaging , Ltd. · Pathology

Feb 2013

Decision

170d

Days

Class 2

Risk

About This 510(k) Submission

K122554 is an FDA 510(k) clearance for the GENASIS 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 , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on February 7, 2013, 170 days after receiving the submission on August 21, 2012. This device falls under the Pathology review panel. Regulated under 21 CFR 866.4700.

Submission Details

510(k) Number	K122554 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2012
Decision Date	February 07, 2013
Days to Decision	170 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