Cleared Traditional

K062756 - PATHIAM IMAGING SOFTWARE FOR HER2/NEU

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

FDA 510(k) Submission Details - K062756

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.

NOT Device Classification - Class ,

Product Code NOT
Device Class -