Cleared Traditional

K251952 - Virasight

K251952 is an FDA 510(k) clearance for Virasight, manufactured by Virasoft Corporation. The device is a Class 2 Pathology device with product code PSY cleared through the Traditional 510(k) pathway after a 387-day FDA review.

K251952 · Virasoft Corporation · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
387d
Days
Class 2
Risk

K251952 is an FDA 510(k) clearance for the Virasight. Classified as Whole Slide Imaging System (product code PSY), Class II - Special Controls.

Submitted by Virasoft Corporation (New York City, US). The FDA issued a Cleared decision on July 17, 2026 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Virasoft Corporation devices

FDA 510(k) Submission Details - K251952

510(k) Number K251952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2025
Decision Date July 17, 2026
Days to Decision 387 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
310d slower than avg
Panel avg: 77d · This submission: 387d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 19
Devices cleared under the same product code (PSY) and FDA review panel - the closest regulatory comparables to K251952.
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Philips IntelliSite Pathology Solution
K241871 · Philips Medical Systems Nederland B.V. · Dec 2024
Philips IntelliSite Pathology Solution 5.1
K233204 · Philips Medical Systems Nederland B.V. · Jun 2024