Cleared Traditional

ARIOL

K033200 · Applied Imaging Corp. · Pathology

Mar 2004

Decision

168d

Days

Class 2

Risk

About This 510(k) Submission

K033200 is an FDA 510(k) clearance for the ARIOL, a Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (Class II — Special Controls, product code NQN), submitted by Applied Imaging Corp. (Santa Clara, US). The FDA issued a Cleared decision on March 18, 2004, 168 days after receiving the submission on October 2, 2003. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number	K033200 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 2003
Decision Date	March 18, 2004
Days to Decision	168 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Statement

Device Classification

Product Code	NQN — Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.1860
Definition	Automated Microscopic Immunohistochemistry Image- Analysis System To Measure Nuclear Intensity And Percent Positivity With Operator Intervention.