Cleared Traditional

K062756 - PATHIAM IMAGING SOFTWARE FOR HER2/NEU (FDA 510(k) Clearance)

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

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 after a review of 159 days - an extended review cycle.

This device falls under the Pathology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bioimagene, Inc. devices

Submission Details

510(k) Number K062756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 77d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOT
Device Class -