K242600 is an FDA 510(k) clearance for the Second Opinion Periapical Radiolucency Contours. 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 April 11, 2025, 224 days after receiving the submission on August 30, 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 | K242600 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2024 |
| Decision Date | April 11, 2025 |
| Days to Decision | 224 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 |