Aperio Epathology Eihc IVD System

Q: What is the product code of K141109?

The FDA product code is NOT – Microscope, Automated, Image Analysis, Operator Intervention, a Class II (moderate risk) device regulated under 21 CFR 864.1860.

FDA 510(k) K141109 · Leica Biosystems Imaging, Inc.

Substantially Equivalent

510(k) numberK141109

Submission

Device name: Aperio Epathology Eihc IVD System
Applicant: Leica Biosystems Imaging, Inc.
Vista, CA, US
Received: April 29, 2014
Decision date: July 29, 2014
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NOT – Microscope, Automated, Image Analysis, Operator Intervention
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.1860
Specialty: Hematology

Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.

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K080564	Scanscope XT SystemNOT · Traditional	Aperio Technologies	08/14/2009SE
K080910	Pathiam System for HER2/NEU Immunohistochemistry Reagents & KitsNOT · Traditional	Bioimagene, Inc.	02/04/2009SE
K071128	Scanscope XT SystemNOT · Traditional	Aperio Technologies	10/10/2007SE
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K051282	Ventana Image Analysis System - HER2/NEUNOT · Traditional	Tripath Imaging, Inc.	08/16/2005SE

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Questions and answers

When was Aperio Epathology Eihc IVD System cleared by the FDA?

Aperio Epathology Eihc IVD System (K141109) received a 510(k) decision of Substantially Equivalent on July 29, 2014, 91 days after the submission was received.

What is the product code of K141109?

The FDA product code is NOT – Microscope, Automated, Image Analysis, Operator Intervention, a Class II (moderate risk) device regulated under 21 CFR 864.1860.