Cleared Traditional

PHILIPS HERCEPTEST DIGITAL SCORE

K130021 · Philips Medical Systems Nederland B.V. · Pathology
Sep 2013
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K130021 is an FDA 510(k) clearance for the PHILIPS HERCEPTEST DIGITAL SCORE, a Automated Digital Image Manual Interpretation Microscope (Class II — Special Controls, product code OEO), submitted by Philips Medical Systems Nederland B.V. (Best Noord-Brabant, NL). The FDA issued a Cleared decision on September 19, 2013, 259 days after receiving the submission on January 3, 2013. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K130021 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2013
Decision Date September 19, 2013
Days to Decision 259 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.