K250264 is an FDA 510(k) clearance for the SugarBug (1.x). This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Bench7, Inc. (Bismarck, US). The FDA issued a Cleared decision on November 7, 2025, 282 days after receiving the submission on January 29, 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 | K250264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2025 |
| Decision Date | November 07, 2025 |
| Days to Decision | 282 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 |