K243239 is an FDA 510(k) clearance for the Lung AI (LAI001). This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Exo, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 24, 2025, 196 days after receiving the submission on October 10, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2070. For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers.
| 510(k) Number | K243239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2024 |
| Decision Date | April 24, 2025 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MYN - Analyzer, Medical Image |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2070 |
| Definition | For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers |