Cleared Traditional

K141109 - APERIO EPATHOLOGY EIHC IVD SYSTEM

K141109 · Leica Biosystems Imaging, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
91d
Days
-
Risk

K141109 is an FDA 510(k) clearance for the APERIO EPATHOLOGY EIHC IVD SYSTEM.

Submitted by Leica Biosystems Imaging, Inc. (Vista, US). The FDA issued a Cleared decision on July 29, 2014 after a review of 91 days - within the typical 510(k) review window.

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 Leica Biosystems Imaging, Inc. devices

FDA 510(k) Submission Details - K141109

510(k) Number K141109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2014
Decision Date July 29, 2014
Days to Decision 91 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
13d slower than avg
Panel avg: 78d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

NOT Device Classification - Class ,

Product Code NOT
Device Class -

Regulatory Peers - NOT

All 10
Devices cleared under the same product code (NOT) and FDA review panel - the closest regulatory comparables to K141109.
OptraSCAN System
K260755 · Optrascan, Inc. · Jul 2026
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K121033 · Ventana Medical Systems, Inc. · Sep 2013
VIRTUSO SYSTEM FOR IHC (DO-7)
K121350 · Ventana Medical Systems, Inc. · Jun 2012
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K111755 · Ventana Medical Systems, Inc. · Feb 2012
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
K111543 · Ventana Medical Systems, Inc. · Oct 2011
SCANSCOPE XT SYSTEM
K080564 · Aperio Technologies · Aug 2009