Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
The automated immunohistochemistry image analysis microscope system with operator intervention for nuclear intensity and percent positivity is a hematology and pathology device that automates measurement of nuclear staining intensity and the percentage of positively stained cells in immunohistochemistry specimens, with operator input during analysis. 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 NQN is not eligible for third-party review.
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Basic Information
- Product Code
- NQN
- 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 nuclear intensity and percent positivity with operator intervention.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140957 | GENASIS HIPATH IHC FAMILY | Jan 15, 2015 | Substantially Equivalent | Applied Spectral Imaging , Ltd. |
| K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER | Mar 20, 2014 | Substantially Equivalent | Ventana Medical Systems, Inc. |
| K130515 | VIRTUOSO SYSTEM FOR IHC ER (SPI) | Nov 22, 2013 | Substantially Equivalent | Ventana Medical Systems, Inc. |
| K121516 | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) | Sep 26, 2013 | Substantially Equivalent | Ventana Medical Systems, Inc. |
| K122143 | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER | Sep 19, 2013 | Substantially Equivalent | Ventana Medical Systems, Inc. |
| K111872 | VIRTUOSO SYSTEM FOR IHC P53 (DO-7) | Apr 19, 2012 | Substantially Equivalent | Ventana Medical Systems, Inc. |
| K111869 | VIRTUOSO SYSTEM FOR IHC PR (IE2) | Mar 05, 2012 | Substantially Equivalent | Ventana Medical Systems, Inc. |
| K092333 | PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 | Oct 27, 2010 | Substantially Equivalent | Bioimagene, Inc. |
| K073677 | SCANSCOPE XT SYSTEM | Aug 01, 2008 | Substantially Equivalent | Aperio Technologies |
| K061613 | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) | Jan 10, 2007 | Substantially Equivalent | Tripath Imaging |
| K062428 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS | Sep 29, 2006 | Substantially Equivalent | Tripath Imaging, Inc. |
| K053520 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 | Apr 11, 2006 | Substantially Equivalent | Tripath Imaging, Inc. |
| K050012 | VENTANA IMAGE ANALYSIS SYSTEM | May 06, 2005 | Substantially Equivalent | Tripath Imaging, Inc. |
| K033200 | ARIOL | Mar 18, 2004 | Substantially Equivalent | Applied Imaging Corp. |
| K031363 | QCA (VERSION 3.1) | Feb 05, 2004 | Substantially Equivalent | Cell Analysis, 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.