Cleared Traditional

K111543 - VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)

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

FDA 510(k) Submission Details - K111543

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 77d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

NOT Device Classification - Class ,

Product Code NOT
Device Class -