Cleared Traditional

K071128 - SCANSCOPE XT SYSTEM (FDA 510(k) Clearance)

K071128 · Aperio Technologies · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
170d
Days
-
Risk

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 after a review of 170 days - an extended review 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: 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 Aperio Technologies devices

Submission Details

510(k) Number K071128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 77d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOT
Device Class -