K243234 is an FDA 510(k) clearance for the Second Opinion® CS. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Pearl, Inc. (Beverly Hills, US). The FDA issued a Cleared decision on June 12, 2025, 245 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 | K243234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2024 |
| Decision Date | June 12, 2025 |
| Days to Decision | 245 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 |