K251934 is an FDA 510(k) clearance for the qXR-Detect. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Qure.Ai Technologies (Mumbai, IN). The FDA issued a Cleared decision on January 16, 2026, 206 days after receiving the submission on June 24, 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 | K251934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2025 |
| Decision Date | January 16, 2026 |
| Days to Decision | 206 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 |