510(k) K051282
- Device
- VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU
- Applicant
- TRIPATH IMAGING, INC.
- 510(k) number
- K051282
- Product code
- NOT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-08-16
- Date received
- 2005-05-17
- Regulation
- 864.1860
- Classification name
- Microscope, Automated, Image Analysis, Operator Intervention
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRYAN J TUCKER
- Address
- 4025 Stirrup Creek Dr., Suite 400 Durham NC US 27703 27703
FDA Registration Numbers#
- 2028492
- 3003537036
- 9615060
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NOT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K141109 | APERIO EPATHOLOGY EIHC IVD SYSTEM | Leica Biosystems Imaging, Inc. | 2014-07-29 |
| K121033 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | Ventana Medical Systems, Inc. | 2013-09-06 |
| K121350 | VIRTUSO SYSTEM FOR IHC (DO-7) | Ventana Medical Systems, Inc. | 2012-06-01 |
| K111755 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | Ventana Medical Systems, Inc. | 2012-02-22 |
| K111543 | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) | Ventana Medical Systems, Inc. | 2011-10-12 |
| K080564 | SCANSCOPE XT SYSTEM | Aperio Technologies | 2009-08-14 |
| K080910 | PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS | Bioimagene, Inc. | 2009-02-04 |
| K071128 | SCANSCOPE XT SYSTEM | Aperio Technologies | 2007-10-10 |
| K062756 | PATHIAM IMAGING SOFTWARE FOR HER2/NEU | Bioimagene, Inc. | 2007-02-20 |
| K031715 | ARIOL HER-2/NEU IHC | Applied Imaging Corp. | 2004-01-08 |
| K032113 | ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | Chroma Vision Medical Systems, Inc. | 2003-12-23 |
Legacy Summary#
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FDA Review#
Decision Summary