Cleared Traditional

K080564 - SCANSCOPE XT SYSTEM (FDA 510(k) Clearance)

K080564 · Aperio Technologies · Pathology device
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Aug 2009
Decision
533d
Days
-
Risk

K080564 is an FDA 510(k) clearance for the SCANSCOPE XT SYSTEM.

Submitted by Aperio Technologies (Vista, US). The FDA issued a Cleared decision on August 14, 2009 after a review of 533 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Pathology submissions.

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Submission Details

510(k) Number K080564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2008
Decision Date August 14, 2009
Days to Decision 533 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
456d slower than avg
Panel avg: 77d · This submission: 533d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOT
Device Class -