VIRTUSO SYSTEM FOR IHC (DO-7)
FDA 510(k) clearance K121350 · decided 2012-06-01
Clearance details
- K-number
- K121350
- Device name
- VIRTUSO SYSTEM FOR IHC (DO-7)
- Applicant
- Ventana Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-05-04
- Decision date
- 2012-06-01
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- NOT
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OptraSCAN System (K260755) | Optrascan, Inc. | 2026-07-02 |
| APERIO EPATHOLOGY EIHC IVD SYSTEM (K141109) | Leica Biosystems Imaging, Inc. | 2014-07-29 |
| VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (K121033) | Ventana Medical Systems, Inc. | 2013-09-06 |
| VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (K111755) | Ventana Medical Systems, Inc. | 2012-02-22 |
| VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) (K111543) | Ventana Medical Systems, Inc. | 2011-10-12 |
| SCANSCOPE XT SYSTEM (K080564) | Aperio Technologies | 2009-08-14 |
| PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS (K080910) | Bioimagene, Inc. | 2009-02-04 |
| SCANSCOPE XT SYSTEM (K071128) | Aperio Technologies | 2007-10-10 |
| PATHIAM IMAGING SOFTWARE FOR HER2/NEU (K062756) | Bioimagene, Inc. | 2007-02-20 |
| VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU (K051282) | Tripath Imaging, Inc. | 2005-08-16 |
| ARIOL HER-2/NEU IHC (K031715) | Applied Imaging Corp. | 2004-01-08 |
| ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) (K032113) | Chroma Vision Medical Systems, Inc. | 2003-12-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S059) | Ventana Medical Systems, Inc. | 2025-12-15 |
| HER2 Dual ISH DNA Probe Cocktail (P190031/S014) | Ventana Medical Systems, Inc. | 2025-12-15 |
| CINtec PLUS Cytology (P190024/S015) | Ventana Medical Systems, Inc. | 2025-09-04 |
| CINtec PLUS Cytology (P190024/S014) | Ventana Medical Systems, Inc. | 2025-07-31 |
| VENTANA CLDN18 (43-14A) RxDx Assay (P230018/S001) | Ventana Medical Systems, Inc. | 2025-06-20 |
| PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S057) | Ventana Medical Systems, Inc. | 2025-06-20 |
| VENTANA ALK (D5F3) CDX ASSAY (P140025/S025) | Ventana Medical Systems, Inc. | 2025-06-20 |
| VENTANA PD-L1 (SP263) ASSAY (P160046/S020) | Ventana Medical Systems, Inc. | 2025-06-20 |