Cleared Traditional

VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) (K111543) - FDA 510(k) Clearance

K111543 · Ventana Medical Systems, Inc. · Pathology device
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Oct 2011
Decision
132d
Days
-
Risk

K111543 is an FDA 510(k) clearance for the VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5).

Submitted by Ventana Medical Systems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 12, 2011 after a review of 132 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 Ventana Medical Systems, Inc. devices

Submission Details

510(k) Number K111543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2011
Decision Date October 12, 2011
Days to Decision 132 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
55d slower than avg
Panel avg: 77d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOT
Device Class -