510(k) K061613
K061613 is an FDA 510(k) premarket notification submitted by Tripath Imaging for the device "VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)". The FDA issued a decision of Substantially Equivalent on January 10, 2007. The device falls under product code NQN (Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity), a Class II device regulated under 21 CFR 864.1860. Tripath Imaging has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 2007
- Date Received
- June 9, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
- Device Class
- Class II
- Regulation Number
- 864.1860
- Review Panel
- PA
- Submission Type
Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.