RevealAI-Lung— 510(k) K251769
Substantially EquivalentPrecision Medical Ventures, Inc. Dba Revealdx
FDA 510(k) clearance K251769 for RevealAI-Lung, Substantially Equivalent on 2026-01-30. Applicant: Precision Medical Ventures, Inc. Dba Revealdx. Device class: 2.
Clearance details
- Applicant
- Precision Medical Ventures, Inc. Dba Revealdx
- Product code
- Code POK
- Device class
- Class 2
- Regulation
- 21 CFR 892.2060
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Recent devices under product code POK
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