FDA.report

510(k) K251769

Device
RevealAI-Lung
Applicant
Precision Medical Ventures, Inc. Dba Revealdx
510(k) number
K251769
Product code
POK
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-30
Date received
2025-06-10
Regulation
892.2060
Classification name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Michael Calhoun
Address
1800 Westlake Ave. N., Suite 104 Seattle WA US 98109 98109

FDA Registration Numbers

Source Documents

510(k) summary PDF

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