Virasight— 510(k) K251952
Substantially EquivalentVirasoft Corporation
FDA 510(k) clearance K251952 for Virasight, Substantially Equivalent on 2026-07-17. Applicant: Virasoft Corporation. Device class: 2.
Summary
Virasight from Virasoft is filed under PSY, whole slide imaging systems. The record doesn't describe the product's components or outputs.
Class II, 21 CFR 864.3700. Pathology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Virasoft filed from New York City, New York. Review took 387 calendar days (June 25, 2025 to July 17, 2026).
Clearance details
- Applicant
- Virasoft Corporation
- Product code
- Product code PSY
- Device class
- Class 2
- Regulation
- 21 CFR 864.3700
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York City, NY, US
Recent devices under product code PSY
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