Cleared Traditional

SCANSCOPE XT SYSTEM

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

About This 510(k) Submission

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, 533 days after receiving the submission on February 28, 2008. This device falls under the Pathology review panel.

Submission Details

510(k) Number K080564 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NOT
Device Class —

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