qXR-Detect
FDA 510(k) K251934 · Qure.Ai Technologies
510(k) numberK251934
Submission
- Device name
- qXR-Detect
- Applicant
- Qure.Ai Technologies
Mumbai, IN - Received
- June 24, 2025
- Decision date
- January 16, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MYN – Analyzer, Medical Image
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2070
- Specialty
- Radiology
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
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More from Videahealth, Inc.
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| K231805 | qXR-LNMYN · Traditional | 12/22/2023SE |
| K231149 | qXR-CTRQIH · Traditional | 09/22/2023SE |
| K230899 | qXR-PTX-PEQFM · Traditional | 08/22/2023SE |
| K212690 | qXR-BTQIH · Traditional | 12/21/2021SE |
| K211222 | qER-QuantQIH · Traditional | 07/30/2021SE |
| K200921 | qERQAS · Traditional | 06/17/2020SE |
Questions and answers
When was qXR-Detect cleared by the FDA?
qXR-Detect (K251934) received a 510(k) decision of Substantially Equivalent on January 16, 2026, 206 days after the submission was received.
What is the product code of K251934?
The FDA product code is MYN – Analyzer, Medical Image, a Class II (moderate risk) device regulated under 21 CFR 892.2070.