Cleared Traditional

SCANSCOPE XT SYSTEM

K080254 · Aperio Technologies · Pathology

Oct 2008

Decision

274d

Days

Class 2

Risk

About This 510(k) Submission

K080254 is an FDA 510(k) clearance for the SCANSCOPE XT SYSTEM, a Automated Digital Image Manual Interpretation Microscope (Class II — Special Controls, product code OEO), submitted by Aperio Technologies (Vista, US). The FDA issued a Cleared decision on October 31, 2008, 274 days after receiving the submission on January 31, 2008. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number	K080254 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2008
Decision Date	October 31, 2008
Days to Decision	274 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	OEO — Automated Digital Image Manual Interpretation Microscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.1860
Definition	The Ihc Her2 Manual Read Of A Digital Slide Application Is Intended For Use As An Aid To The Pathologist In The Detection And Semi-quantitative Measurement Of Her2/neu (c-erbb-2) In Formalin-fixed, Paraffin-embedded Normal And Neoplastic Tissue Immunohistochemically Stained For Her-2 Receptors, Using Microscopy Images Displayed On A Computer Monitor. Her-2 Results Are Indicated For Use As An Aid In The Management, Prognosis And Prediction Of Therapy Outcomes In Breast Cancer.