Scanscope XT System

FDA 510(k) K071671 · Aperio Technologies

Substantially Equivalent

510(k) numberK071671

Submission

Device name
Scanscope XT System
Applicant
Aperio Technologies
Vista, CA, US
Received
June 19, 2007
Decision date
December 28, 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
OEO – Automated Digital Image Manual Interpretation Microscope
Device class
Class II (moderate risk)
Regulation
21 CFR 864.1860
Specialty
Hematology

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…

Other 510(k)s with product code OEO

510(k)DeviceApplicantDecision
K142965Virtuoso System for IHC PR (1E2) using iScan HTOEO · Traditional Ventana Medical Systems, Inc.07/16/2015SE
K131140Omnyx Idp for HER2 Manual ApplicationOEO · Traditional Omnyx, LLC04/01/2014SE
K130021Philips Herceptest Digital ScoreOEO · Traditional Philips Medical Systems Nederland B.V.09/19/2013SE
K111914Virtual Slide System, Olympus VS800 SystemOEO · Traditional Olympus America Inc. / Scientific Equipment Group08/21/2012SE
K080254Scanscope XT SystemOEO · Traditional Aperio Technologies10/31/2008SE

More from Aperio Technologies

510(k)DeviceDecision
K080564Scanscope XT SystemNOT · Traditional 08/14/2009SE
K080254Scanscope XT SystemOEO · Traditional 10/31/2008SE
K073677Scanscope XT SystemNQN · Traditional 08/01/2008SE
K071128Scanscope XT SystemNOT · Traditional 10/10/2007SE

Questions and answers

When was Scanscope XT System cleared by the FDA?

Scanscope XT System (K071671) received a 510(k) decision of Substantially Equivalent on December 28, 2007, 192 days after the submission was received.

What is the product code of K071671?

The FDA product code is OEO – Automated Digital Image Manual Interpretation Microscope, a Class II (moderate risk) device regulated under 21 CFR 864.1860.