PATHIAM IMAGING SOFTWARE FOR HER2/NEU
FDA 510(k) clearance K062756 · decided 2007-02-20
Clearance details
- K-number
- K062756
- Device name
- PATHIAM IMAGING SOFTWARE FOR HER2/NEU
- Applicant
- Bioimagene, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-14
- Decision date
- 2007-02-20
- Days to decision
- 159 days
- Clearance type
- Traditional
- Product code
- NOT
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Cupertino, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| OptraSCAN System (K260755) | Optrascan, Inc. | 2026-07-02 |
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| VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (K121033) | Ventana Medical Systems, Inc. | 2013-09-06 |
| VIRTUSO SYSTEM FOR IHC (DO-7) (K121350) | Ventana Medical Systems, Inc. | 2012-06-01 |
| 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 |
| 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.