| K141109 | APERIO EPATHOLOGY EIHC IVD SYSTEM | LEICA BIOSYSTEMS IMAGING, INC. |
| K121350 | VIRTUSO SYSTEM FOR IHC (DO-7) | VENTANA MEDICAL SYSTEMS, INC. |
| K121033 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | VENTANA MEDICAL SYSTEMS, INC. |
| K111755 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | VENTANA MEDICAL SYSTEMS, INC. |
| K111543 | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) | VENTANA MEDICAL SYSTEMS, INC. |
| K080910 | PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS | BIOIMAGENE, INC. |
| K080564 | SCANSCOPE XT SYSTEM | APERIO TECHNOLOGIES |
| K071128 | SCANSCOPE XT SYSTEM | APERIO TECHNOLOGIES |
| K062756 | PATHIAM IMAGING SOFTWARE FOR HER2/NEU | BIOIMAGENE, INC. |
| K051282 | VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU | TRIPATH IMAGING, INC. |
| K032113 | ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | CHROMA VISION MEDICAL SYSTEMS INC. |
| K031715 | ARIOL HER-2/NEU IHC | APPLIED IMAGING CORP. |