Cleared Traditional

PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67

K092333 · Bioimagene, Inc. · Pathology

Oct 2010

Decision

449d

Days

Class 2

Risk

About This 510(k) Submission

K092333 is an FDA 510(k) clearance for the PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67, a Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (Class II — Special Controls, product code NQN), submitted by Bioimagene, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 27, 2010, 449 days after receiving the submission on August 4, 2009. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number	K092333 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2009
Decision Date	October 27, 2010
Days to Decision	449 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	NQN — Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.1860
Definition	Automated Microscopic Immunohistochemistry Image- Analysis System To Measure Nuclear Intensity And Percent Positivity With Operator Intervention.