qXR-LN
FDA 510(k) K231805 · Qure.Ai Technologies
510(k) numberK231805
Submission
- Device name
- qXR-LN
- Applicant
- Qure.Ai Technologies
Mumbai, IN - Received
- June 20, 2023
- Decision date
- December 22, 2023
- 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
Other 510(k)s with product code MYN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252486 | ChestView US (1.1)MYN · Traditional | Gleamer | 09/09/2026SE |
| K261059 | Overjet Multi-Image Caries and Charting AssistMYN · Traditional | Overjet, Inc. | 08/06/2026SE |
| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0MYN · Traditional | Better Diagnostics AI Corp. | 07/15/2026SE |
| K252953 | Velmeni for Dentists (V4D) Endo-PerioMYN · Traditional | Velmeni, Inc. | 05/11/2026SE |
| K251934 | qXR-DetectMYN · Traditional | Qure.Ai Technologies | 01/16/2026SE |
| K252934 | DiagnocatMYN · Traditional | Dgnct, LLC | 01/15/2026SE |
| K253009 | DS Core DetectMYN · Traditional | Dentsply Sirona, Inc. | 01/07/2026SE |
| K252086 | DTX Studio AssistMYN · Traditional | Nobel Biocare C/O Medicim NV | 11/17/2025SE |
| K250525 | Second Opinion® PanoramicMYN · Traditional | Pearl, Inc. | 11/14/2025SE |
| K250264 | SugarBug (1.x)MYN · Traditional | Bench7, Inc. | 11/07/2025SE |
More from Bench7, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251934 | qXR-DetectMYN · Traditional | 01/16/2026SE |
| K251610 | qER-CTA (v1.0)QAS · Traditional | 09/08/2025SE |
| K240740 | qCT LN QuantQIH · Traditional | 08/16/2024SE |
| 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-LN cleared by the FDA?
qXR-LN (K231805) received a 510(k) decision of Substantially Equivalent on December 22, 2023, 185 days after the submission was received.
What is the product code of K231805?
The FDA product code is MYN – Analyzer, Medical Image, a Class II (moderate risk) device regulated under 21 CFR 892.2070.