Scanscope XT System

Q: What is the product code of K071128?

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) K071128 · Aperio Technologies

Substantially Equivalent

510(k) numberK071128

Submission

Device name: Scanscope XT System
Applicant: Aperio Technologies
Vista, CA, US
Received: April 23, 2007
Decision date: October 10, 2007
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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K111543	Virtuoso (TM) System for Ihc HER2 (4B5)NOT · Traditional	Ventana Medical Systems, Inc.	10/12/2011SE
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
K062756	Pathiam Imaging Software for HER2/NEUNOT · Traditional	Bioimagene, Inc.	02/20/2007SE
K051282	Ventana Image Analysis System - HER2/NEUNOT · Traditional	Tripath Imaging, Inc.	08/16/2005SE

More from Tripath Imaging, Inc.

510(k)	Device	Decision
K080564	Scanscope XT SystemNOT · Traditional	08/14/2009SE
K080254	Scanscope XT SystemOEO · Traditional	10/31/2008SE
K073677	Scanscope XT SystemNQN · Traditional	08/01/2008SE
K071671	Scanscope XT SystemOEO · Traditional	12/28/2007SE

Questions and answers

When was Scanscope XT System cleared by the FDA?

Scanscope XT System (K071128) received a 510(k) decision of Substantially Equivalent on October 10, 2007, 170 days after the submission was received.

What is the product code of K071128?

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