K223811 is an FDA 510(k) clearance for the Lung-CAD. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Imagen Technologies, Inc. (New York, US). The FDA issued a Cleared decision on September 13, 2023, 267 days after receiving the submission on December 20, 2022.
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 | K223811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2022 |
| Decision Date | September 13, 2023 |
| Days to Decision | 267 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 |