Cleared Traditional

K253554 - Aperio GT 450 DX

Also marketed or referenced as:
Aperio GT 180 DX

K253554 is an FDA 510(k) clearance for Aperio GT 450 DX, manufactured by Leica Biosystems Imaging, Inc.. The device is a Class 2 Pathology device with product code PSY cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K253554 · Leica Biosystems Imaging, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
266d
Days
Class 2
Risk

K253554 is an FDA 510(k) clearance for the Aperio GT 450 DX. Classified as Whole Slide Imaging System (product code PSY), Class II - Special Controls.

Submitted by Leica Biosystems Imaging, Inc. (Vista, US). The FDA issued a Cleared decision on August 7, 2026 after a review of 266 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3700 - the FDA pathology device framework. 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 - K253554

510(k) Number K253554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2025
Decision Date August 07, 2026
Days to Decision 266 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 77d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

PSY Device Classification - Class 2, Special Controls

Product Code PSY Whole Slide Imaging System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.3700
Definition The Whole Slide Imaging System Is An Automated Digital Slide Creation, Viewing, And Management System Intended As An Aid To The Pathologist To Review And Interpret Digital Images Of Surgical Pathology Slides Prepared From Formalin-fixed, Paraffin-embedded (ffpe) Tissue. The System Generates Digital Images That Would Otherwise Be Appropriate For Manual Visualization By Conventional Brightfield Microscopy. The Whole Slide Imaging System Is Not Intended For Use With Slides Prepared From Frozen Tissue, Cytology, And Non-ffpe Hematopathology Specimens (e.g., Peripheral Blood Smear).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Peers - PSY Whole Slide Imaging System

All 22
Devices cleared under the same product code (PSY) and FDA review panel - the closest regulatory comparables to K253554.
NanoZoomer S540MD Slide Scanner System
K260964 · Hamamatsu Photonics K.K. · Jul 2026
Virasight
K251952 · Virasoft Corporation · Jul 2026
NanoZoomer S20MD Slide scanner system
K253606 · Hamamatsu Photonics K.K. · Jul 2026
Philips IntelliSite Pathology Solution 5.1
K243871 · Philips Medical Systems Nederland B.V. · Mar 2025
E1000 Dx Digital Pathology Solution
K241717 · Shandon Diagnostics Limited · Feb 2025
Roche Digital Pathology Dx
K242783 · Ventana Medical Systems, Inc. · Dec 2024