Cleared Traditional

VIRTUSO SYSTEM FOR IHC (DO-7) (K121350) - FDA 510(k) Clearance

K121350 · Ventana Medical Systems, Inc. · Pathology device
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Jun 2012
Decision
28d
Days
-
Risk

K121350 is an FDA 510(k) clearance for the VIRTUSO SYSTEM FOR IHC (DO-7).

Submitted by Ventana Medical Systems, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 1, 2012 after a review of 28 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ventana Medical Systems, Inc. devices

Submission Details

510(k) Number K121350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2012
Decision Date June 01, 2012
Days to Decision 28 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
49d faster than avg
Panel avg: 77d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOT
Device Class -