510(k) K251769
K251769 is an FDA 510(k) premarket notification submitted by Precision Medical Ventures, Inc. Dba Revealdx for the device "RevealAI-Lung". The FDA issued a decision of Substantially Equivalent on January 30, 2026. The device falls under product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer), a Class II device regulated under 21 CFR 892.2060.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2026
- Date Received
- June 10, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- Device Class
- Class II
- Regulation Number
- 892.2060
- Review Panel
- RA
- Submission Type
Assist users in characterizing lesions identified on acquired medical images