Cleared Traditional

PATHIAM IMAGING SOFTWARE FOR HER2/NEU

K062756 · Bioimagene, Inc. · Pathology
Feb 2007
Decision
159d
Days
—
Risk

About This 510(k) Submission

K062756 is an FDA 510(k) clearance for the PATHIAM IMAGING SOFTWARE FOR HER2/NEU, submitted by Bioimagene, Inc. (Cupertino, US). The FDA issued a Cleared decision on February 20, 2007, 159 days after receiving the submission on September 14, 2006. This device falls under the Pathology review panel.

Submission Details

510(k) Number K062756 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2006
Decision Date February 20, 2007
Days to Decision 159 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code NOT
Device Class —

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