Lung AI (LAI001)— 510(k) K243239
Substantially EquivalentExo, Inc.
FDA 510(k) clearance K243239 for Lung AI (LAI001), Substantially Equivalent on 2025-04-24. Applicant: Exo, Inc.. Device class: 2.
Clearance details
- Applicant
- Exo, Inc.
- Product code
- Code MYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.2070
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
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