Ventana Image Analysis System - HER2/NEU
FDA 510(k) K051282 · Tripath Imaging, Inc.
510(k) numberK051282
Submission
- Device name
- Ventana Image Analysis System - HER2/NEU
- Applicant
- Tripath Imaging, Inc.
Durham, NC, US - Received
- May 17, 2005
- Decision date
- August 16, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NOT – Microscope, Automated, Image Analysis, Operator Intervention
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1860
- Specialty
- Hematology
Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.
Other 510(k)s with product code NOT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260755 | OptraSCAN SystemNOT · Traditional | Optrascan, Inc. | 07/02/2026SE |
| K141109 | Aperio Epathology Eihc IVD SystemNOT · Traditional | Leica Biosystems Imaging, Inc. | 07/29/2014SE |
| K121033 | Virtuoso System for Ihc KI-67 (30-9)NOT · Traditional | Ventana Medical Systems, Inc. | 09/06/2013SE |
| K121350 | Virtuso System for Ihc (DO-7)NOT · Traditional | Ventana Medical Systems, Inc. | 06/01/2012SE |
| K111755 | Virtuoso System for Ihc KI-67 (30-9)NOT · Traditional | Ventana Medical Systems, Inc. | 02/22/2012SE |
| K111543 | Virtuoso (TM) System for Ihc HER2 (4B5)NOT · Traditional | Ventana Medical Systems, Inc. | 10/12/2011SE |
| K080564 | Scanscope XT SystemNOT · Traditional | Aperio Technologies | 08/14/2009SE |
| K080910 | Pathiam System for HER2/NEU Immunohistochemistry Reagents & KitsNOT · Traditional | Bioimagene, Inc. | 02/04/2009SE |
| K071128 | Scanscope XT SystemNOT · Traditional | Aperio Technologies | 10/10/2007SE |
| K062756 | Pathiam Imaging Software for HER2/NEUNOT · Traditional | Bioimagene, Inc. | 02/20/2007SE |
More from Bioimagene, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061613 | Ventana Image Analysis System - Pathway HER2 (4B5)NQN · Traditional | 01/10/2007SE |
| K062428 | Ventana Image Analysis System, Model ViasNQN · Traditional | 09/29/2006SE |
| K053520 | Ventana Image Analysis System, Model KI-67NQN · Traditional | 04/11/2006SE |
| K050012 | Ventana Image Analysis SystemNQN · Traditional | 05/06/2005SE |
Questions and answers
When was Ventana Image Analysis System - HER2/NEU cleared by the FDA?
Ventana Image Analysis System - HER2/NEU (K051282) received a 510(k) decision of Substantially Equivalent on August 16, 2005, 91 days after the submission was received.
What is the product code of K051282?
The FDA product code is NOT – Microscope, Automated, Image Analysis, Operator Intervention, a Class II (moderate risk) device regulated under 21 CFR 864.1860.