Cleared Traditional

K051282 - VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU

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

FDA 510(k) Submission Details - K051282

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.

NOT Device Classification - Class ,

Product Code NOT
Device Class -