Cleared Traditional

SCANSCOPE XT SYSTEM

K073677 · Aperio Technologies · Pathology

Aug 2008

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K073677 is an FDA 510(k) clearance for the SCANSCOPE XT SYSTEM, a Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (Class II — Special Controls, product code NQN), submitted by Aperio Technologies (Vista, US). The FDA issued a Cleared decision on August 1, 2008, 217 days after receiving the submission on December 28, 2007. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number	K073677 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 2007
Decision Date	August 01, 2008
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

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.