Cleared Traditional

SCANSCOPE XT SYSTEM

K071128 · Aperio Technologies · Pathology
Oct 2007
Decision
170d
Days
Risk

About This 510(k) Submission

K071128 is an FDA 510(k) clearance for the SCANSCOPE XT SYSTEM, submitted by Aperio Technologies (Vista, US). The FDA issued a Cleared decision on October 10, 2007, 170 days after receiving the submission on April 23, 2007. This device falls under the Pathology review panel.

Submission Details

510(k) Number K071128 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2007
Decision Date October 10, 2007
Days to Decision 170 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code NOT
Device Class

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