Automated Digital Image Manual Interpretation Microscope
The Automated Digital Image Manual Interpretation Microscope (product code OEO) is a hematology/pathology device intended to aid pathologists in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) expression in formalin-fixed, paraffin-embedded tissue using immunohistochemically stained digital microscopy images displayed on a computer monitor; HER2 results support management, prognosis, and prediction of therapy outcomes in breast cancer. This device is FDA Class 2 under regulation 864.1860 in the Hematology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OEO
- Device Class
- FDA class 2
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HT | Jul 16, 2015 | Substantially Equivalent | Ventana Medical Systems, Inc. |
| K131140 | OMNYX IDP FOR HER2 MANUAL APPLICATION | Apr 01, 2014 | Substantially Equivalent | Omnyx, LLC |
| K130021 | PHILIPS HERCEPTEST DIGITAL SCORE | Sep 19, 2013 | Substantially Equivalent | Philips Medical Systems Nederland B.V. |
| K111914 | VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM | Aug 21, 2012 | Substantially Equivalent | Olympus America Inc. / Scientific Equipment Group |
| K080254 | SCANSCOPE XT SYSTEM | Oct 31, 2008 | Substantially Equivalent | Aperio Technologies |
| K071671 | SCANSCOPE XT SYSTEM | Dec 28, 2007 | Substantially Equivalent | Aperio Technologies |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.