510(k) K092333
K092333 is an FDA 510(k) premarket notification submitted by Bioimagene, Inc. for the device "PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67". The FDA issued a decision of Substantially Equivalent on October 27, 2010. 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. Bioimagene, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2010
- Date Received
- August 4, 2009
- 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.