Ventana Image Analysis System, Model Vias
FDA 510(k) K062428 · Tripath Imaging, Inc.
510(k) numberK062428
Submission
- Device name
- Ventana Image Analysis System, Model Vias
- Applicant
- Tripath Imaging, Inc.
Durham, NC, US - Received
- August 18, 2006
- Decision date
- September 29, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NQN – Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1860
- Specialty
- Hematology
Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.
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| K073677 | Scanscope XT SystemNQN · Traditional | Aperio Technologies | 08/01/2008SE |
| K061613 | Ventana Image Analysis System - Pathway HER2 (4B5)NQN · Traditional | Tripath Imaging | 01/10/2007SE |
More from Tripath Imaging
| 510(k) | Device | Decision |
|---|---|---|
| K061613 | Ventana Image Analysis System - Pathway HER2 (4B5)NQN · Traditional | 01/10/2007SE |
| K053520 | Ventana Image Analysis System, Model KI-67NQN · Traditional | 04/11/2006SE |
| K051282 | Ventana Image Analysis System - HER2/NEUNOT · Traditional | 08/16/2005SE |
| K050012 | Ventana Image Analysis SystemNQN · Traditional | 05/06/2005SE |
Questions and answers
When was Ventana Image Analysis System, Model Vias cleared by the FDA?
Ventana Image Analysis System, Model Vias (K062428) received a 510(k) decision of Substantially Equivalent on September 29, 2006, 42 days after the submission was received.
What is the product code of K062428?
The FDA product code is NQN – Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity, a Class II (moderate risk) device regulated under 21 CFR 864.1860.