VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
FDA 510(k) clearance K140465 · decided 2014-03-20
Clearance details
- K-number
- K140465
- Device name
- VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
- Applicant
- Ventana Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-02-24
- Decision date
- 2014-03-20
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- NQN
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| GENASIS HIPATH IHC FAMILY (K140957) | Applied Spectral Imaging , Ltd. | 2015-01-15 |
| VIRTUOSO SYSTEM FOR IHC ER (SPI) (K130515) | Ventana Medical Systems, Inc. | 2013-11-22 |
| VIRTUOSO SYSTEM FOR IHC HER2 (4B5) (K121516) | Ventana Medical Systems, Inc. | 2013-09-26 |
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| PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 (K092333) | Bioimagene, Inc. | 2010-10-27 |
| SCANSCOPE XT SYSTEM (K073677) | Aperio Technologies | 2008-08-01 |
| VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) (K061613) | Tripath Imaging | 2007-01-10 |
| VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS (K062428) | Tripath Imaging, Inc. | 2006-09-29 |
| VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 (K053520) | Tripath Imaging, Inc. | 2006-04-11 |
| VENTANA IMAGE ANALYSIS SYSTEM (K050012) | Tripath Imaging, Inc. | 2005-05-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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| 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 |