Microscope, Automated, Image Analysis, Operator Intervention
The automated microscope image analysis system with operator intervention is a hematology and pathology device that uses automated immunohistochemistry image analysis to measure cell membrane intensity and staining patterns, with operator input required during the analysis process. It is classified as FDA Class 2 under regulation 864.1860 in the Hematology specialty (reviewed by Pathology panel), requiring 510(k) clearance. Product code NOT is not eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- NOT
- Device Class
- FDA class 2
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
Definition
Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K141109 | APERIO EPATHOLOGY EIHC IVD SYSTEM | Jul 29, 2014 | Substantially Equivalent | Leica Biosystems Imaging, Inc. |
| K121033 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | Sep 06, 2013 | Substantially Equivalent | Ventana Medical Systems, Inc. |
| K121350 | VIRTUSO SYSTEM FOR IHC (DO-7) | Jun 01, 2012 | Substantially Equivalent | Ventana Medical Systems, Inc. |
| K111755 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | Feb 22, 2012 | Substantially Equivalent | Ventana Medical Systems, Inc. |
| K111543 | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) | Oct 12, 2011 | Substantially Equivalent | Ventana Medical Systems, Inc. |
| K080564 | SCANSCOPE XT SYSTEM | Aug 14, 2009 | Substantially Equivalent | Aperio Technologies |
| K080910 | PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS | Feb 04, 2009 | Substantially Equivalent | Bioimagene, Inc. |
| K071128 | SCANSCOPE XT SYSTEM | Oct 10, 2007 | Substantially Equivalent | Aperio Technologies |
| K062756 | PATHIAM IMAGING SOFTWARE FOR HER2/NEU | Feb 20, 2007 | Substantially Equivalent | Bioimagene, Inc. |
| K051282 | VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU | Aug 16, 2005 | Substantially Equivalent | Tripath Imaging, Inc. |
| K031715 | ARIOL HER-2/NEU IHC | Jan 08, 2004 | Substantially Equivalent | Applied Imaging Corp. |
| K032113 | ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | Dec 23, 2003 | Substantially Equivalent | Chroma Vision Medical Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.