K230085 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 October 3, 2023, 265 days after receiving the submission on January 11, 2023.
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 | K230085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2023 |
| Decision Date | October 03, 2023 |
| Days to Decision | 265 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 |