Cleared Traditional

K051282 - VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU (FDA 510(k) Clearance)

K051282 · Tripath Imaging, Inc. · Pathology device
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Aug 2005
Decision
91d
Days
-
Risk

K051282 is an FDA 510(k) clearance for the VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU.

Submitted by Tripath Imaging, Inc. (Durham, US). The FDA issued a Cleared decision on August 16, 2005 after a review of 91 days - within the typical 510(k) review window.

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 Tripath Imaging, Inc. devices

Submission Details

510(k) Number K051282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2005
Decision Date August 16, 2005
Days to Decision 91 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 77d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOT
Device Class -