Cleared Traditional

K071128 - SCANSCOPE XT SYSTEM

K071128 · Aperio Technologies · Pathology device
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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.

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FDA 510(k) Submission Details - K071128

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 78d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

NOT Device Classification - Class ,

Product Code NOT
Device Class -

Regulatory Peers - NOT

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