Virasight
FDA 510(k) clearance K251952 · decided 2026-07-17
Clearance details
- K-number
- K251952
- Device name
- Virasight
- Applicant
- Virasoft Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-06-25
- Decision date
- 2026-07-17
- Days to decision
- 387 days
- Clearance type
- Traditional
- Product code
- PSY
- Device class
- 2
- Regulation number
- 864.3700
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- New York City, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.