K250525 is an FDA 510(k) clearance for the Second Opinion® Panoramic. 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 November 14, 2025, 266 days after receiving the submission on February 21, 2025.
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 | K250525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2025 |
| Decision Date | November 14, 2025 |
| Days to Decision | 266 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 |