K242522 is an FDA 510(k) clearance for the Second Opinion CC. 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 January 16, 2025, 146 days after receiving the submission on August 23, 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 | K242522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2024 |
| Decision Date | January 16, 2025 |
| Days to Decision | 146 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 |