NOT — Microscope, Automated, Image Analysis, Operator Intervention Class II
FDA product code NOT covers "Microscope, Automated, Image Analysis, Operator Intervention", a Class II medical device regulated under 21 CFR 864.1860. Submissions are reviewed by the Hematology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NOT
- Device Class
- Class II
- Regulation Number
- 864.1860
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Definition
Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260755 | optrascan | OptraSCAN System | July 2, 2026 |
| K141109 | leica biosystems imaging | APERIO EPATHOLOGY EIHC IVD SYSTEM | July 29, 2014 |
| K121033 | ventana medical systems | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | September 6, 2013 |
| K121350 | ventana medical systems | VIRTUSO SYSTEM FOR IHC (DO-7) | June 1, 2012 |
| K111755 | ventana medical systems | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | February 22, 2012 |
| K111543 | ventana medical systems | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) | October 12, 2011 |
| K080564 | aperio technologies | SCANSCOPE XT SYSTEM | August 14, 2009 |
| K080910 | bioimagene | PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS | February 4, 2009 |
| K071128 | aperio technologies | SCANSCOPE XT SYSTEM | October 10, 2007 |
| K062756 | bioimagene | PATHIAM IMAGING SOFTWARE FOR HER2/NEU | February 20, 2007 |
| K051282 | tripath imaging | VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU | August 16, 2005 |
| K031715 | applied imaging | ARIOL HER-2/NEU IHC | January 8, 2004 |
| K032113 | chroma vision medical systems | ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | December 23, 2003 |